Pfizer is hiring B. Pharm/ M. Pharm as a Associate II – Regulatory Affairs – Apply Now

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Unlock your potential with Pfizer as we’re on the lookout for talented individuals with backgrounds in B.Pharm, M.Pharm, M.Sc, B.Sc, or Pharm.D to join us as Associate II in Regulatory Affairs. Take the next step in your career journey with a globally renowned pharmaceutical leader, where your expertise will play a vital role in navigating regulatory landscapes. Discover exciting opportunities with Pfizer today!

Position: Associate II – Regulatory Affairs

Department: Regulatory Affairs

Education: B.Pharm, M.Pharm, M.Sc, B.Sc, Pharm.D, M.Tech, B.Tech

Job Location: Chennai

Job Description

As An Associate II In Regulatory Affairs, You Will Represent Pfizer As An Approval Liaison In The Regulatory Affairs Team. You Will Play A Critical Role In Providing Strategic Product Direction To Teams, Interacting With Regulatory Agencies, And Negotiating To Expedite Approval Of Pending Registrations. You Will Be The Regulatory Liaison On The Project Team Throughout The Product Lifecycle And A Regulatory Representative To Marketing Or Research Project Teams And Government Regulatory Agencies. Your Understanding Of Regulatory Procedures Will Facilitate The Development And Submission Of Product Registrations, Progress Reports, Supplements, Amendments, And Periodic Experience Reports.

How You Will Achieve It

1. Contribute To The Completion Of Project Milestones And Organize Your Work To Meet Project Task Deadlines.
2. Ensure Team Compliance With Submission Standards, Procedures, And Policies Framed By Global Regulatory Affairs.
3. Prepare And Finalize Global Regulatory Strategy Documents (GRSD), Comparative Toxicogenomics Database (CTD) Sections Of Supplements/Variations For Lifecycle Management (LCM) Submissions, Ensuring Effective Data Presentation And Quality.
4. Provide Regulatory Support To Cross-Functional Teams For Assigned Products, Participating In Technical Reviews And Strategic Discussions On Regulatory Submissions.
5. Provide Regulatory Inputs For The Approval Of Promotional Materials Following Applicable Regulatory Requirements And Pfizer Policies.
6. Identify And Assess Regulatory Risks Associated With Assigned Projects And Communicate Them Timely To Mitigate Risks.
7. Liaise With Key Stakeholders To Ensure Filing Strategies Are Defined And Executed, And Board Of Health (BoH) Requirements Are Met, Ensuring A Submission-Ready Dossier.
8. Track Commitments Made To Health Authorities And Ensure Timely Closure.
9. Manage Continuous Improvement Of Selected Processes Relating To Human Health Submissions And Selected Drug And Non-Drug-Specific Projects And Related Activities.
10. Maintain Required Regulatory Databases To Ensure Compliance.
11. Stay Updated On The External Regulatory Environment, Including Competitor Intelligence, Local Product, And International Regulatory And Commercial Strategies.

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Qualifications:

1. Bachelor’s Degree
2. Proven Ability To Manage Complex Regulatory Or Drug Development Issues
3. Knowledge Of Regulations And Guidelines In Various Markets
4. Strong Relationships With Local Health Agencies And Other Relevant Stakeholders
5. Good Communication, Collaboration, Negotiation, And Problem-Solving Skills
6. Fluent In English, Written And Spoken
7. Computer Literacy And Ability To Learn New Systems

Nice-To-Have:

1. Knowledge Of Regulatory Processes And Documents, Therapeutic Areas
2. Strategic Thinking With Good Project Management Skills

Work Location Assignment: Flexible

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