DDReg Pharma

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DDReg Pharma
Full Time
Gurgaon
Posted 1 month ago
Job purpose: To visually communicate ideas, messages, and information through creative and compelling designs. They combine artistic skills with technical expertise to create visual content that resonates with target audiences and achieves specific communication goals. Ultimately, their role is to enhance the visual identity and effectiveness of brands, products, or messages.   Duties and Responsibilities
  • Create visually appealing graphics, layouts, and design elements for print and digital media.
  • Develop marketing materials, including brochures, flyers, posters, banners, social media graphics, and digital advertisements.
  • Adhere to brand guidelines and complete projects according to deadline.
  • Design social media graphics for various platforms.
  • Create web graphics, including website banners, icons, and infographics.
  • Contribute ideas and concepts for design projects.
  • Collaborate with creative director and other designers to develop design concepts.
  • Utilize graphic design software such as Adobe Creative Suite (Photoshop, Illustrator, InDesign), Canva etc.
  • Retouch and manipulate images using Adobe Photoshop and Illustrator.
Education & Experience
  • Bachelor’s degree in graphic design, computer science or related field
  • 2+ years of experience
Knowledge, Skills, and Abilities
  • Experience with video editing and motion graphics.
  • Knowledge of HTML/CSS for basic web design.
  • Familiarity with content management systems (CMS)
  • Strong portfolio of graphic design work.
  • Proficient in Adobe Creative Suite (Photoshop, Illustrator, InDesign, etc.).
  • Excellent communication and teamwork skills.
  • Ability to work independently and as part of a team.
  • Strong attention to detail and deadlines.
Location
  • Gurgaon (On-site)

Job purpose: To visually communicate ideas, messages, and information through creative and compelling designs. They combine artistic skills with technical expertise to create visual content that reson...

Full Time
Gurgaon
Posted 3 months ago
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 position will oversee the team of 2-5 team members to manage filings in key markets by DDReg. The responsibility include review of technical documents/dossiers, preparation and submission of Submission dossiers in CTD format, ePublish them (wherever applicable), response to queries, post approval life cycle management etc. 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 and responsibilities
  • 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
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 15+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 5+ with an overall team size of 40 RA professionals Location Gurgaon, Haryana (INDIA)

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...

Full Time
Gurgaon
Posted 3 months ago
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 reports. Responsibilities
  • 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
Qualifications
  • 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
Location Gurgaon

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...

Full Time
Gurgaon
Posted 3 months ago
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 Regulatory Guidelines Duties and responsibilities
  • 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
Education & Experience
  • 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
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 Direct reports: Nil Location: Gurgaon

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 Technical documentation & dossiers for Various Markets in compliance to applicable regulations and guidelines. Duties and responsibilities: • 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 Education & Experience: • Master’s degree in Pharma discipline 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: 0 to start with Location: 1. Gurgaon

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 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 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 and 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 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
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, Haryana (INDIA)

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...

Full Time
Gurgaon
Posted 3 months ago
JOB DESCRIPTION Job TitleRegulatory 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 products. Education & Experience:
  • MSc. Biotechnology
  • 3+ years of experience in handling Regulatory Affairs function.
Roles & Responsibilities:
  • 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.
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.
Location: Gurgaon /Mumbai No. of Openings: 3 positions

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...

Full Time
Gurgaon
Posted 3 months ago
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 Technical documentation & dossiers for Various Markets in compliance to applicable regulations and guidelines. Duties and responsibilities: • 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 Education & Experience: • Master’s degree in Pharma discipline with 2 years experience 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: 0 to start with Location: 1. Gurgaon 2. Mumbai

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...

Full Time
Gurgaon
Posted 3 months ago
JOB DESCRIPTION Job TitleDigital 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 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. Education & Experience:
  • Degree in Marketing, Communication, Information Technology, or a related field.
  • 2+ years of Experience
Roles & Responsibilities:
  • 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
Knowledge, Skills and Abilities:
  • 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.
LocationGurgaon

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...