Associate II Reg Strategy, GRS Oncology at Pfizer | Pharmacy Graduates Apply
A Pfizer Regulatory Affairs Job is available for B Pharm/MPharm graduates to join Pfizer as an Associate II in Reg Strategy for GRS Oncology in Chennai, India. This full-time position offers an opportunity to contribute to the regulatory landscape while ensuring that life-saving treatments reach patients in need.
About the company
Pfizer is a global pharmaceutical company dedicated to delivering innovative medicines and vaccines to improve health outcomes worldwide. Operating in various therapeutic areas, Pfizer focuses on research and development, manufacturing, and marketing of healthcare products. The company is committed to adhering to local and global regulations, ensuring that its products meet the highest standards of quality and safety.
Job Details
- Company: Pfizer
- Location: Chennai, Tamil Nadu, India
- Job Requisition ID: 4964681
- Employment Type: Full time
- Posted On: Today
Pfizer Regulatory Affairs Job Description
In this Pfizer Regulatory Affairs Job, the Associate II will collaborate with Global Regulatory Leads and product teams on lifecycle maintenance submissions and regulatory activities. The position requires strategic expertise in lifecycle maintenance submission activities, CMC Module 1 document preparation, and safety compliance reporting. The Associate II will play a critical role in ensuring that Pfizer’s treatments are compliant with evolving regulations.
Key Responsibilities
- Coordinate lifecycle activities, including variations, supplements, amendments, renewals, and withdrawals for assigned regions.
- Lead regional regulatory strategies in agreement with key stakeholders for assigned projects/products.
- Ensure alignment of regulatory positions and submission approaches across global, regional, and country stakeholders.
- Author and QC electronic applications and submission packages as requested.
- Perform quality checks of eAF CMC content for completeness and accuracy.
- Prepare and coordinate submission components such as cover letters and application forms.
- Support responses to Health Authority questions and collaborate with country and regional colleagues.
- Build effective working relationships with various regulatory teams and participate in project meetings.
Eligibility Criteria
- Bachelor’s or master’s degree in pharmacy, life sciences, chemistry, biotechnology, or a related discipline.
- 2 to 4 years of relevant regulatory experience in the pharmaceutical industry.
- Working knowledge of pharmaceutical regulatory submissions and product lifecycle management.
- Strong communication and presentation skills.
- Ability to manage multiple priorities in a complex global environment.
Preferred Qualifications
- Master’s degree in pharmacy, regulatory affairs, or a related discipline.
- Experience supporting oncology or biologics product portfolios.
- Hands-on experience with post-approval variations and CMC submissions.
- Knowledge of major regulatory frameworks and submission procedures.
How to Apply
Interested candidates can apply for the position through the following link:
CLICK HERE FOR THE ORIGINAL NOTIFICATION
Conclusion
This Pfizer Regulatory Affairs Job presents a significant opportunity for qualified candidates to contribute to the vital field of regulatory affairs. Interested individuals are encouraged to apply through the official Pfizer application link to be part of a team dedicated to improving global health through innovative solutions.
