You will be responsible for driving the digital visibility of our organization If you have SEO skills and a passion driving traffic to websites. As SEO executive, you’ll work closely with our Front-End developers, Digital marketing and Business Development team members to ensure system consistency and improve user experience.

Accountabilities

• Developing & implementing and developing SEO & SMO strategies
• Researching the competitors, both on-site and off-site
• Writing engaging SEO content along with the Content.
• Optimizing content regularly on the website.
• Google/ Social Media Ads

Major Activities

• Off page
• On page
• Social media Optimization
• Analyse competitor’s website
• Creation of description content or small article for submission
• Contact with Website Manager to update content on website
• Generation of Reports on every 15^th Day of month
• Create and Optimize ads

Major Challenges

• Staying up to date with the latest Google Algorithm changes

Educational Qualification

Bachelor’s degree in Marketing, Communication, Information Technology, or a related field.

Skills

• Ability to work independently or in a team environment as and when required.
• Demonstrate excellent keyword research techniques.
• Strong decision making and reasoning skills.
• Work experience as an SEO Executive, SEO Specialist, or a similar position.
• Excellent understanding and experience with website analytics tools like Moz, Google Analytics, etc
• Basic knowledge of HTML and CSS.

Relevant and total years of Experience

• At least 1 Year

To Manage Regulatory Affairs for EU/Canada/Australia Markets in compliance to applicable regulations and guidelines. This position will assist with the review of CMS documentations, preparation and submission of eCTDs, Variations, site transfers and post approval gap analysis. This position will also provide support of the regulatory function through document management, electronic submission compilation and management, and other group management activities as required. Position will be required to work with Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Research and Development groups of the client organization of DDReg.

Duties & Responsibilities

• Providing high-quality CMC review of technical documentation for regulatory filings to European Medicinal Agency (EMA), UK MHRA, National Agencies of EU Member states, Canada, Australia for DDReg clients.
• Running De-centralized Procedures, MRP and procedures for national filings in EU Members states, Health Canada, TGA Australia
• Actively contribute to the development and implementation of regulatory strategies, processes and timelines for EU/UK/Australia/ Canada and global approval.
• Prepares and compiles new CTDs, Variations (Major/Minor/Site Transfers) filings ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
• Critically reviews documentation intended for submission to the above mentioned agencies, internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.
• Demonstrate subject matter and area expertise.
• Collaborate with internal and external clients,
• Supporting and enabling effective and efficient communication that results in operational excellence.
• Providing technical consultation and provides substantive advice on strategy, regulations and industry best practices.
• Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on agencies website.
• Monitor competitive regulatory practices, and actively review internal and external factors to mitigate potential problems.
• Ensure that draft labeling complies with all applicable regulations and guidelines

Education & Experience

• Bachelor’s or Master’s degree in Pharma.
• Previous experience that provides the knowledge, skills and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience.
• Experience working in the pharmaceutical/CRO industry preferred.

Knowledge, Skills and Abilities

• Excellent technical data interpretation skills
• Strong project management skills
• Excellent interpersonal skills including problem solving
• Strong negotiation skills
• Excellent oral and written communication skills with strong presentation skills
• Significant knowledge of global, regional, national and other document development guidelines
• In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
• Great judgment and decision-making skills
• Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
• Ability and desire to work in a team-oriented environment.
• Excellent written and verbal communication skills
• Highly proficient with Microsoft Word, PowerPoint and Excel.
• Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
• Possesses a collaborative, results-driven style.
• Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines

Other requirements

As may be required from time to time – the incumbent may be required to working slots catering to different time zones

Direct reports

• 1-4 to start with

Location

• Gurgaon

Plan and implement strategies to build a world class team by recruiting aggressively and making sure the workforce availability.

Accountabilities

• Plan and implement strategies to build a world class team by recruiting aggressively and making sure the workforce availability.
• To ensure all tasks related to HR Operations are as per SLA's
• Develop, design and formulate, with inputs from the Leadership, HR Policies and Processes
• Development of Employer Branding and defining its metrics
• Assess training needs to apply and monitor training programs.
• Oversee and manage a performance appraisal system that drives high performance
• Administer employee benefits program and employee engagement including upskilling, health insurance, employee wellness and employee grievances handling and adequate HR compliance.
• Manager HR Team

Major Activities

• To build strategies for early/infant attrition (90 day quit rate/360 degree quit The number of hires that leave the company within 3 months or a year.)
• To set recruitment metrics for better workforce.
• To work in building TAT for each task in HR Operations.
• To ensure the tasks are completed within set timelines.
• To ensure all day to day operational issues and grievances are addressed within set guidelines.
• To maintain smooth functioning of other departments.
• Refer to best practices prevalent across the industry and within ConAgra and then formulate the ATFL HR policies.
• Propose the policy to the Leadership and make amendments based on discussions and get the sign off for organisation wide implementation
• Design HR processes to compliment the policies for all aspects of HR with variances in the processes for all levels.
• Create a step by step manual for the Policies & Processes in order to ensure that the information is able to spread across all levels
• Implement, monitor and improve Performance Management System and coordinate annual reviews.
• Defining metrics which make sure people know about the brand.
• To set up and ensure regular social media engagement on platforms like linkedin.
• Working on improving rating of company on platforms like glass door.
• Creating and Measuring Candidate experience
• To analyze the employee referral rate
• To set up the training calendar to track all training programs and employee participation. Attendance.
• To ensure employees complete assessments based on the trainings and ensure Re-assessments in case of failures.
• To evaluate and work on the current PMS structure.
• To ensure all the employees across are aware of the evaluation criteria. To set SLAs to fill in and complete the Goals and Objectives and quarterly feedback by the employees and managers. To make sure the set timelines are followed in filling performance management and the appraisal sheets by employees and manager respectively.
• To plan activities to build employee engagement within company.
• To establish activities around employee wellness every quarter.
• Set TATs to clear HR compliance related queries/complaint for closure.
• To plan and structure HR team and their KPIs especially recruitment
• Supervise performance of each member of the HR Team

Educational Qualifications

• MBA in HR

Functional Skills

• HR Policies
• ATS and HRIS portal
• Grievance Handling
• HR Operations
• Payroll Management
• Stakeholder Management
• New Hire Orientation
• Performance Management
• Employee Engagement
• Business Partnering
• Learning and Development
• Agility
• Employee Benefits

Skills

• Team management
• Analytical thinking

Relevant and total years of Experience

• 8 Years and above

To ensure that the below-listed tasks should be done carefully for a successful submission, and approval of the assigned products.

• Reviewing of the DS part of the dossier for the US, EU, and ROW.
• Reviewing of SFDA templates and compiled a dossier of Drug Substances.
• Reviewing of e-Functionalities and eCTD published dossiers.
• Level-2 review of Analytical method validations.
• DMF review and gap sheet release for US, EU, and ROW.
• Preparation of Query responses and client responses.
• Archival of master data and emails received from respective clients.
• Review of Product History Sheet & management of the data in the server of the respective projects.
• Updated guidelines review.
• Self-training and improvement.

PRINCIPAL ACCOUNTABILITIES

Accountabilities	Major Activities	Key Performance Indicators
Review of the DS part of the dossier for the US, EU, and ROW.	Review of Drug substance-related modules in the dossier for the US, and ROW.	Ensure timely closure of assigned activities and accuracy in the work
Reviewing of SFDA templates and compiled a dossier of Drug Substances.	Final review of SFDA templates and compiled dossier for Saudi with respect to the drug substance.	Ensure timely closure of assigned activities and accuracy in the work
Reviewing of e-Functionalities and eCTD published dossiers	Final review of e-functionality check and published dossiers with respect to the drug substance.	Ensure timely closure of assigned activities and accuracy in the work
Level-2 review of Analytical method validations.	Review of drug substance validations for both DSM and DPM sites.	Ensure timely closure of assigned activities and accuracy in the work
DMF review and gap sheet release for US, EU, and ROW.	Base DMF review and gap sheet preparation/updates for US, EU, and ROW.	Ensure timely closure of assigned activities and accuracy in the work
Preparation of Query responses and client responses.	Preparation of action items against queries received from the agency and releasing of responses to clients.	Ensure timely closure of assigned activities and accuracy in the work
Archival of master data and emails received from respective clients.	Doing archival on daily basis for assigned projects within folders as per SOPs and review of monthly archival reports.	Accuracy in the Archival

SKILLS AND KNOWLEDGE

Educational Qualifications

M.Sc Biotechnology

Functional Skills

Team management Collaborative working skills Trainings for within the team and CFT

Relevant and total years of Experience

6.5 Years

To provide Regulatory Affairs support for EU in compliance to applicable regulations and guidelines. This position will provide support of the regulatory function through document management, electronic submission compilation and management, and other group management activities as required. Position will be required to work with Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Research and Development groups of the client organization of DDReg.

Duties and responsibilities

• Compilation of module 1 for Life cycle applications suitable for submission in Europe until End of procedure/approval.
• Compilation of module 1 New MAA suitable for submission in Europe until End of Procedure/approval.
• Necessary communications & subsequent follow up (keeping Reporting Manager in loop) with different stake holders (e.g. Manufacturing, QA, QC, Procurement, ADL, etc.) to get required data / documents for compilation of package
• Publishing of eCTD sequence and upload onto agency portal.
• Updating company databases with approved regulatory information as per company SOP.
• Compilation of suitable for submission in Europe until End of procedure/approval.
• Compilation of new CTDs, Life cycle applications (i.e Variations -Major/Minor/Site Transfers) ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
• Compilation of New MAA suitable for submission in Europe until End of Procedure/approval.
• Critically reviews documentation intended for submission to the above mentioned agencies, internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.
• Demonstrate subject matter and area expertise.
• Collaborate with internal and external clients,
• Supporting and enabling effective and efficient communication that results in operational excellence.
• Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on agencies website.

Education & Experience

• Bachelor's or Master’s degree in Pharma
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience.
• Experience working in the pharmaceutical/CRO industry preferred

Knowledge, Skills and Abilities

• Excellent technical data interpretation skills
• Strong project management skills
• Excellent interpersonal skills including problem solving
• Strong negotiation skills
• Excellent oral and written communication skills with strong presentation skills
• Significant knowledge of global, regional, national and other document development guidelines
• In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
• Great judgment and decision-making skills
• Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
• Ability and desire to work in a team-oriented environment.
• Excellent written and verbal communication skills
• Highly proficient with Microsoft Word, PowerPoint and Excel.
• Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
• Possesses a collaborative, results-driven style.
• Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines

Other requirements

As may be required from time to time – the incumbent may be required to working slots catering to different time zones

Reports To : Director

To plan and Manage Medical Writing for Regulatory and Pharmacovigilance Verticals in compliance to applicable regulatory and Regulatory Guidelines

Duties and responsibilities

• To plan and Manage Medical Writing for Regulatory and Pharmacovigilance Verticals in compliance to applicable regulatory and Regulatory Guidelines
• Providing technical consultation and provides substantive advice on strategy, regulations and industry best practices.
• Demonstrate subject matter and therapeutic area expertise.
• Effectively manage medical writing projects to deliver quality products in agreed timelines.
• Collaborate with internal and external clients,
• Writing CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Safety Reports, Aggregate Reports and other reports
• Perform science review of aggregate reports produced by PV Associates
• Ensure that document output and processes comply with client specifications, templates and styles guidelines
• Attend project initiation meeting, collate project brief.
• Maintain awareness of current regulatory guidance, medical information techniques and technology relating to clinical / regulatory documentation
• Maintain & update Aggregate Report Tracker and carry out cases reconciliation on periodic basis
• Supporting and enabling effective and efficient communication that results in operational excellence.
• Carry out detailed searches in regulatory agency websites like US FDA, EMA, PMDA, TGA, UKMHRA etc for safety alerts
•  Mentor Associates on job skills, oversees or develops training plans or materials for safety associates, conducts training sessions, or otherwise trains new hires and enhances the skills of existing personnel.

Education & Experience

• Master's degree in a Pharmacology/Pharmacy/Medicine
• Advanced degree preferred
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years’) or equivalent combination of education, training, & experience.
• Experience working in the pharmaceutical/CRO industry preferred
• Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous

Knowledge, Skills and Abilities

• Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
• Strong project management skills
• Excellent interpersonal skills including problem solving
• Strong negotiation skills
• Excellent oral and written communication skills with strong presentation skills
• Significant knowledge of global, regional, national and other document development guidelines
• In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
• Great judgment and decision-making skills
• Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
• Ability and desire to work in a team-oriented environment.
• Excellent written and verbal communication skills
• Highly proficient with Microsoft Word, PowerPoint and Excel.
• Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
• Possesses a collaborative, results-driven style.
• Ability to work under pressure and provide quality outputs within tight timelines

Other requirements

As may be required from time to time – the incumbent may be required to working slots catering to different time zones

Job purpose

To carry out Regulatory Review and Compilation of Technical documentation & dossiers as part of Life Cycle Management of products in compliance to applicable regulations and guidelines.

Education & Experience

• Master’s degree in Pharma discipline.
• 3 + years of experience in handling Regulatory Affairs function.

Knowledge, Skills and Abilities

• Excellent technical data interpretation skills.
• Strong project management skills.
• Excellent interpersonal skills including problem solving.
• Strong negotiation skills.
• Excellent oral and written communication skills with strong presentation skills.
• Significant knowledge of global, regional, national and other document development guidelines.
• In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
• Great judgment and decision-making skills.
• Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook).
• Ability and desire to work in a team-oriented environment.
• Excellent written and verbal communication skills.
• Highly proficient with Microsoft Word, PowerPoint and Excel.
• Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner.
• Possesses a collaborative, results-driven style.
• Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines.

Other Requirements

As may be required from time to time – the incumbent may be required to working slots catering to different time zones

• Providing high-quality CMC review of technical documentation i.e CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Labelling documents, for regulatory filings in emerging markets, for DDReg clients.
• Assist in development of high quality dossier for various markets.
• Adequacy Review and Gap Analysis of Technical Documentation for Non-CTD/CTD dossier compilation.
• Closure of comments with the cross functional team & review of additional data generated in response to review comments per country.
• Compilation of Dossier.
• Review of registration dossier (m1-m5) as per country specific regulatory requirements.
• Deficiencies response management from various authorities by coordinating stakeholders for getting documents and compilation and review of response and compile response to queries from the MOH.
• Updation of the dossier as per the queries responded (inclusive of all countries).
• Demonstrate subject matter and area expertise.
• Collaborate with internal and external clients.
• Supporting and enabling effective and efficient communication that results in operational excellence.
• Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on regulatory agency websites.

Location

• Gurgaon,Mumbai

To develop and enrich content for DDReg tools, websites & Social media with new blog posts, guides and marketing copy..

Duties and responsibilities

• Develop content on regulatory affairs from related information available within company
• Research pharma industry-related topics (combining online sources, interviews and studies)
• Write clear marketing copy to promote our services
• Plan and develop audience-oriented content for Case studies, Blogs, Reports, Website, Social media posts, Infographics, Brochure, Video Scripts, JDs, Flyers, Press Releases etc.
• Write blogs on key topics periodically.
• Proficient in using documentation tools (MS Word, Adobe Acrobat Pro, MS Visio, and Adobe Photoshop).
• Ability to understand requirements and deliver clear and concise quality documents.
• Hands-on experience on various tools- content creation, monitoring, content analysis, content enhancement, translation and workflow tools.
• Proofreading content for errors and inconsistencies.
• Creating compelling headlines and body copy that will capture the attention of the target audience.
• Create strong content that fulfills company standards and audience goals.
• Utilize a variety of media forms; include images and charts.
• Analyze current content and make improvements, as necessary.
• Update website content as needed

Education & Experience

• Education & Experience
• Bachelor's degree in Communications, Marketing, English, Life Sciences, Journalism, or related field.
• A portfolio of published articles.
• Proven experience (2-5 years) in content writing, content marketing or copywriting.
• Working knowledge of content management systems.
• Proficient in all Microsoft Office applications.
• Excellent writing and editing skills.
• The ability to work in a fast-paced environment.
• Good time-management skills.
• Experience doing research using multiple sources
• Familiarity with web publications
• Ability to meet deadlines

Knowledge, Skills and Abilities

• Excellent verbal and written communication skills; the ability to call, connect and interact with potential customers
• Persuasive and goal-oriented
• Possesses an energetic, outgoing, and friendly demeanor
• Self-motivated and self-directed
• Able to multitask, prioritize, and manage time efficiently
• Able to work accurately under stress and pressure to meet competing deadlines
• Excellent analytical and time-management skills
• Creative problem solver who thrives when presented with a challenge
• Tenacity to handle rejection and continue on with a positive attitude when reaching next potential client
• Ability to work independently or as an active member of a team
• Strong computer skills, including Microsoft Office Suite (Word, PowerPoint, Outlook, and Excel) and CRM/Salesforce experience preferred

Other requirements

As may be required from time to time – the incumbent may be required to working slots catering to different time zones

Reports to- Head Content & Digital Media Development

To plan and manage the information technology needs and systems, including implementing database and network designs, installing and upgrading software, ensuring systems security and troubleshooting computer issues.

Duties and responsibilities

• Managing and maintaining the organization application and use of technology
• Manage window sever 2003 & 2012 (ADDS, DNS & DHCP)
• Assist & maintain corporate LAN/WAN infra
• Manage system configuration and maintenance, system and program security, planning and directing upgrades and testing operations to ensure optimum system functionality.
• Responsible for configuration and administration of  firewall.
• Configuration and management of Azure cloud for backup purpose.
• Installation & troubleshooting of critical applications
• Troubleshoot and resolve incidents related to hardware, software, network and printers.
• Design, implement and maintain policies, procedures for network administration, usage and disaster recovery.
• Monitoring of the internet and email usage of company employees.
• Providing recommendation for improving the organization’s IT systems, hardware and software upgrades.
• Operating Systems (OS) installation/re-installation upgrades and patches for desktop and server.
• Configuration of Print devices (network and local) on desktops
• Desktop Configuration-Network, mail, client, internet etc.
• Supervise regular back up and restoration of all critical assets.
• Responsible for all IT compliance related activity and software licensing.
• Interact and negotiate with vendors, outsourcers and contractors to secure network products and services.

Education & Experience

• Bachelor’s degree in any discipline
• Advanced degree preferred
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience.
• Experience working in the IT Industry
• Additional qualifications in Computer is advantageous
• Experience of working in a Pharmaceutical setup is mandatory

Knowledge, Skills and Abilities

• Excellent interpersonal skills including problem solving
• Strong negotiation skills
• Excellent oral and written communication skills with strong presentation skills
• Great judgment and decision-making skills
• Ability and desire to work in a team-oriented environment.
• Excellent written and verbal communication skills
• Highly proficient with Microsoft Word, PowerPoint and Excel.
• Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
• Possesses a collaborative, results-driven style.
• Ability to work under pressure and provide quality outputs within tight timelines

Other requirements

As may be required from time to time – the incumbent may be required to working slots catering to different time zones

Reports To : Information System Officer

Skills And Requirements

• Full Stack developer, strong knowledge of JavaScript based framework having working experience in React JS.
• Develop and manage highly trafficked, highly scalable web properties with React.js and Next.js.
• Analyse, design, code, debug, test, document and deploy changes to the system.
• Troubleshooting interface software and debugging application codes.
• Understanding of RESTful APIs/GraphQL, HTML/CSS, ES6 (variables and scoping, array methods), code versioning tools like GIT etc., popular frontend development tools, CI/CD tools, DevOps.
• Have a keen eye to discover, evaluate, and implement new technologies to maximize development efficiency and improve user experience
• Minimum 2years of experience in backend and sound knowledge in JavaScript based framework specially in React.js
• Thorough understanding of React.js and its core principles
• Good Knowledge of Server-Side rendering using Next and Express js
• Knowledge of REACT tools including React.js, Webpack, Redux.
• Experience front-end tooling workflows: Node.js, Next.js, Typescript, etc.
• Should have proven track record of handling projects of significant complexity and optimizing applications for improved performance
• Experience integrating open source and third-party applications into existing systems.
• Good understanding of AJAX, HTML, JavaScript, and CSS

Experience

• Minimum 2 years experience as a React and Node Js Developer (MERN).

Location

• Gurgaon