Biotechnology Jobs at Pfizer in Chennai
Ready to take your regulatory affairs career to the next level? Explore exciting Biotechnology Jobs with Pfizer Careers for the position of Associate II – Reg CMC Strategy in Chennai. This opportunity is ideal for professionals with experience in CMC regulatory affairs, biologics, biosimilars, and global pharmaceutical submissions. Join one of the world’s leading biopharmaceutical companies and contribute to regulatory strategies that support life-changing medicines across international markets.
About Pfizer
Pfizer Careers offers professionals the opportunity to work with one of the world’s leading research-based biopharmaceutical companies. Pfizer is committed to discovering, developing, manufacturing, and delivering innovative medicines and vaccines that improve global health. The company invests heavily in scientific innovation, regulatory excellence, digital transformation, and employee development while maintaining the highest standards of quality, compliance, and patient safety. For professionals seeking long-term Biotechnology Jobs, Pfizer provides outstanding career growth, continuous learning opportunities, global exposure, and the chance to contribute to life-changing healthcare solutions.
Job Details:
- Job Title: Associate II – Regulatory CMC Strategy
- Company: Pfizer
- Location: Chennai, Tamil Nadu, India
- Employment Type: Full-Time
- Work Location: On-Premise
Role Overview
The Associate II – Regulatory CMC Strategy is responsible for managing Chemistry, Manufacturing, and Controls (CMC) regulatory activities related to product renewals and annual reports for global pharmaceutical products. Working under general supervision, the Associate independently manages assigned regulatory submissions while collaborating with Global Regulatory Strategy–CMC (GRS-CMC), Pfizer Global Supply, and cross-functional teams to ensure timely, accurate, and compliant regulatory documentation for global health authorities.
The role requires expertise in regulatory strategy, dossier preparation, lifecycle management, and compliance with international regulatory requirements.
Key Responsibilities
Renewal CMC Strategy and Regulatory Submissions
- Manages day-to-day regulatory activities associated with assigned product renewal applications within established timelines.
- Develops renewal regulatory strategies in collaboration with Global Regulatory Strategy–CMC (GRS-CMC) while considering registered product information.
- Prepares and compiles Chemistry, Manufacturing, and Controls (CMC) documentation for renewal submissions across global markets.
- Authors and maintains regulatory dossier components, including:
- Module 1
- Module 2.3 (Drug Substance and Drug Product)
- Module 3.2 (Drug Substance, Drug Product, Regional Information, and Appendices)
- Coordinates Module 1 and Module 3 ancillary documentation as required.
- Reviews technical documentation and supporting scientific information for regulatory submissions.
- Develops scientific and technical justifications to support regulatory changes.
- Supports preparation of responses to regulatory agency queries and post-submission commitments.
- Collaborates with Pfizer Global Supply and other functional teams to obtain required technical information.
- Interprets and applies global regulatory guidelines during preparation of renewal documentation.
- Identifies potential submission risks, resolves routine regulatory issues, and escalates complex concerns to leadership when necessary.
- Coordinates internal document review, quality checks, and approval workflows.
- Utilizes Pfizer regulatory systems, including:
- PEARL
- GDMS
- PDM
- SPA
- Veeva
- Ensures compliance with Pfizer procedures, training requirements, Product License Agreements (PLAs), and activity tracking processes.
Annual Report CMC Responsibilities
- Manages regulatory activities associated with assigned Annual Reports within defined timelines.
- Reviews manufacturing and regulatory changes made during the reporting period for completeness and accuracy.
- Develops preliminary Annual Report regulatory strategies with guidance from GRS-CMC.
- Authors and compiles Module 1 and Module 3 CMC documentation for Annual Reports.
- Reviews post-approval manufacturing changes and verifies regulatory commitments and approvals.
- Evaluates technical documentation supporting Annual Report submissions.
- Reviews stability data for consistency with regulatory commitments.
- Determines appropriate filing classifications based on current regulatory agency requirements.
- Prepares technical justifications supporting regulatory changes.
- Updates impacted dossier components and supporting documentation.
- Coordinates ancillary documentation and internal approval processes.
- Escalates risks affecting submission timelines and regulatory compliance.
- Maintains regulatory documentation within Pfizer’s electronic document management systems.
Educational Requirements
- Postgraduate degree in:
- Biotechnology
- Life Sciences
- Related scientific disciplines
- Bachelor’s or Master’s degree in Biotechnology, or Science is acceptable.
- Ph.D. in Biotechnology or Biological Sciences is preferred.
Required Qualifications
- 3–5 years of experience in Regulatory Affairs within the pharmaceutical industry.
- Experience managing:
- New regulatory submissions.
- Lifecycle Management (LCM) submissions.
- Global regulatory submissions to agencies such as:
- United States Food and Drug Administration (USFDA)
- European Medicines Agency (EMA)
- Other European Union regulatory authorities.
- Experience with Chemistry, Manufacturing, and Controls (CMC) strategy is preferred.
- Knowledge of regulatory requirements for biologics and biosimilars is advantageous.
- Understanding of post-approval regulatory requirements across global markets.
- Knowledge of regulatory documentation requirements for oral solid dosage forms and sterile injectable products.
Technical Skills for Biotechnology Jobs
- Regulatory strategy development for CMC submissions.
- Preparation and maintenance of CTD Modules 1, 2, and 3.
- Product lifecycle management and post-approval change management.
- Regulatory dossier compilation and documentation.
- Scientific writing and technical justification development.
- Electronic regulatory systems, including:
- PEARL
- GDMS
- PDM
- SPA
- Veeva
- Global regulatory compliance and submission management.
Core Competencies
- Strong analytical and problem-solving abilities.
- Excellent organizational and project management skills.
- Effective verbal and written communication in English.
- Ability to prioritize multiple regulatory projects while meeting strict timelines.
- Attention to detail and commitment to regulatory compliance.
- Ability to work independently with minimal supervision while collaborating across global cross-functional teams.
- Sound decision-making skills with the ability to resolve moderately complex regulatory issues.
- Positive, proactive, and results-oriented approach to work.
