Position: Associate-I Reg CMC at Pfizer
Job Summary: The Associate-I Reg CMC will support Global Regulatory Leads (GRLs) in defining global regulatory submission strategies and ensuring timely and quality regulatory submissions for Post Approval Changes, Original Applications/Global Expansions, and License Maintenance of Biosimilars, Biologics, and Small Molecule products.
Key Responsibilities:
- Provide regulatory support for Biosimilars, Biologics, and Small Molecule development projects and life-cycle changes.
- Collaborate with Project Leads, Product Leads, cross-functional teams, regional regulatory colleagues, external partners, and Global Health Authorities.
- Prepare and maintain core dossiers for original applications and subsequent changes.
- Coordinate Quality Query Responses to deficiency letters from Health Authorities.
- Author quality and timely CMC contributions for license maintenance activities such as US Annual Reports, Renewals, APRR, YBPR, and BPDR.
- Advise on regulatory requirements, coordinate regulatory data needs, and ensure compliance.
- Drive resolution of issues and communicate outcomes to global regulatory management and core teams.
- Ensure compliance with submission standards, procedures, and policies framed by Global Regulatory Sciences.
- Mentor and guide new team members on technical aspects of regulatory requirements and Pfizer systems.
Candidate Profile:
- Bachelor’s or Master’s degree (Biotechnology/Pharmacy/Science) or Ph.D. (Biotechnology/Biological Sciences) or equivalent.
- 3-5 years of experience in the Pharmaceutical Industry, with significant experience in Regulatory Sciences handling new submissions and/or LCM submissions to global health authorities, particularly USFDA, EMA, and other EU authorities.
- Preferable experience in filing sterile injectable submissions.
- Proficient in oral and written English communication.
- Strong conceptual, analytical, problem-solving, and organizational skills.
- Assertive, results-oriented manager with a positive attitude and a sense of urgency.
- Basic knowledge of regulatory requirements for Biologics, Biosimilars, and small molecule development and life-cycle changes for US and/or Europe.
- Knowledge of ICH Guidance (Q, S, E, and M).
- Functional knowledge of manufacturing/pharmaceutical sciences/the pharmaceutical industry.
- Competent in understanding and interpreting regulatory requirements and emerging regulatory landscapes.
- Ability to summarize complex technical data and interpret global/regional CMC regulatory policies.
Additional Information:
- Experience: 3-5 years
- Qualification: M.Pharm, B.Pharm, M.Sc, or Ph.D.
- Location: Chennai
- Industry Type: Pharma / Healthcare / Clinical Research
- End Date: 30th August 2024
