Job Archives
Accountabilities | Major Activities |
Plan and implement strategies to build a world class team by recruiting aggressively and making sure the workforce availability. |
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To ensure all tasks related to HR Operations are as per SLA’s |
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Develop, design and formulate, with inputs from the Leadership, HR Policies and Processes |
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Development of Employer Branding and defining its metrics |
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Assess training needs to apply and monitor training programs. |
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Oversee and manage a performance appraisal system that drives high performance |
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Administer employee benefits program and employee engagement including upskilling, health insurance, employee wellness and employee grievances handling and adequate HR compliance. |
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Manage HR Team |
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- Graduate/Post Graduate Degree
- Relevant qualification in HR
• 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 |
- Team management
- Analytical thinking
Accountabilities Major Activities Plan and implement strategies to build a world class team by recruiting aggressively and making sure the workforce availability. To build strategies for early/...
Job title | Director RA |
Reports to | VP Regulatory Affairs |
- Providing high-quality CMC review of technical documentation for regulatory filings to various markets – key market being ASEAN, LATAM & GCC, for DDReg clients
- Actively contribute to the development and implementation of regulatory strategies, processes and timelines for grant of MAs.
- Prepares and compiles new CTD dossiers, renewals and variations 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 respective agencies for 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.
- Efficiently manage overall team of 40 members by way of mentoring them, enhancing & enriching their regulatory knowledge and skill.
- Manage multiple projects with the help of team, track the status of each project, provide update to management in a time bound manner, monitor efficiency of team members.
- 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 various 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
- Bachelor's or Master’s degree in Pharma
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 15+years’) or equivalent combination of education, training, & experience.
- Experience working in the pharmaceutical/CRO industry preferred
- 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.
Job title Director RA Reports to VP Regulatory Affairs Job purpose To Manage & Drive Regulatory Affairs for Emerging (RoW) Markets/ in compliance to applicable regulations and guidelines. This p...
- Research and monitor regulatory requirements, guidelines, and industry trends from agency websites
- Analize and interpret regulatory information in context and provide concise & accurate summary
- Prepare high-quality, accurate, and compliant regulatory intelligence
- Maintain up-to-date knowledge of global regulations & standards, and their implications
- Assist in the development of regulatory strategies.
- Ensure reports are delivered on time, meeting deadlines, and expectations
- Support regulation submissions as needed
- BSc/B. Pharm in related field (Life Sciences, Pharmacy, Regulatory Affairs, or similar discipline)
- 2+ years of experience in scientific report writing
- Robust research and analytical skills with the ability to process and communicate complex/technical information
- Exceptional English written and verbal communication skills
- Attention to detail and ability to work with highly technical and scientific content
- Time management and organizational skills, with the ability to prioritize tasks effectively
- Familiar with regulations and guidelines (i.e., US FDA, EMA, UK MHRA, ICH)
- Familiar with navigating through regulatory agency websites to search for relevant/applicable guidelines
- A certification in regulatory affairs is a plus
Job Description: Summary In this role, the candidate shall be responsible for researching, analysing, and summarizing complex regulatory information and translating it into insightful and compliant re...
Job title | Medical-Regulatory Writer – Assistant Manager |
Reports to | Director |
- Providing high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external clients.
- 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
- 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
- Master’s degree in a Pharmacology/Pharmacy/Medicine with 5 years Experience
- 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
- 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
Job Description Job title Medical-Regulatory Writer – Assistant Manager Reports to Director Job purpose To plan and Manage Medico-Regulatory Writing for Regulatory in compliance to applicable...
Job Description: Job title Associate – Regulatory Affairs Reports to Senior Associate/Astt Manager/Manager – Regulatory Affairs Job purpose: To carry out Regulatory Review and Compilation of Techn...
Job title | Asst. Manager – Regulatory Affairs – Gurgaon |
Reports to | Director |
- 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
- Bachelor’s or Master’s degree in Pharma with 5 years of Experience
- 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
- 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
Job Description Job title Asst. Manager – Regulatory Affairs – Gurgaon Reports to Director Job purpose To Manage Regulatory Affairs for EU/Canada/Australia Markets in compliance to applicab...
- MSc. Biotechnology
- 3+ years of experience in handling Regulatory Affairs function.
- 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-1 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.
- 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.
JOB DESCRIPTION Job Title: Regulatory Affairs Sr. Associate (API) Job purpose: To ensure that the below-listed tasks should be done carefully for a successful submission, and approval of the assigned...
Job Description: Job title Associate – Regulatory Affairs Reports to Senior Associate/Astt Manager/Manager – Regulatory Affairs Job purpose: To carry out Regulatory Review and Compilation of Techn...
- Bachelor’s degree in computer science, engineering, or related field.
- 1+ years of experience in React.js development
- Develop and maintain user interfaces for web applications using JavaScript, Next.js (Preferred), React JS.
- Work with other developers to design and implement new features.
- Troubleshoot and debug front-end code.
- Stay up to date on the latest React technologies.
- Excellent technical data interpretation skills.
- Excellent oral and written communication skills with strong presentation skills.
- 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.
- 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.
Job Title: Front End Developer (1+ Year Exp) Location: Gurgaon Job Type: Full Time Education & Experience: Bachelor’s degree in computer science, engineering, or related field. 1+ years of exp...
- Degree in Marketing, Communication, Information Technology, or a related field.
- 2+ years of Experience
- 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
- 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.
JOB DESCRIPTION Job Title: Digital Marketing (SEO) Job Purpose: You will be responsible for driving the digital visibility of our organization If you have SEO skills and a passion driving traffic to...