Pfizer Chennai Hiring Regulatory Affairs Fresher Opportunities Await

About Pfizer: A Gateway to Regulatory Excellence

Welcome to Pfizer, a global leader in the pharmaceutical industry, committed to discovering innovative solutions that improve health and well-being around the world. We are thrilled to announce exclusive job opportunities for freshers in the Regulatory Affairs department in the vibrant city of Chennai.

Pfizer Regulatory Affairs Fresher Job Vacancies Chennai

Join us as an Associate I – Reg CMC Strategy, Brands CMC and be a part of our commitment to regulatory excellence.

Job Description

As an Associate I – Reg CMC Strategy, Brands CMC, you will play a pivotal role in managing day-to-day regulatory activities associated with assigned Annual Reports. Here’s a glimpse of your responsibilities:

1. Annual Report Management:
   • Manage day-to-day regulatory activities associated with assigned Annual Reports within agreed upon timelines.
   • Review changes made during the reporting period for completeness and accuracy.
   • Develop initial Annual Report regulatory strategy, considering registered content and seeking endorsement by the CMC GRL.
2. Authorship and Compilation:
   • Author and/or compile CMC contributions based on changes made during the appropriate reporting period.
   • Review all appropriate systems for post-approval changes submitted and approved along with commitments made and fulfilled.
3. Quality Assurance and Compliance:
   • Review technical/supportive information for submission to support AR changes.
   • Manage and review stability contributions for accuracy and consistency with commitments.
   • Apply pertinent US regulatory guidelines to confirm Annual Reportable filing classifications.
4. Documentation and Coordination:
   • Develop technical justifications for changes for agency submission as needed.
   • Update impacted dossier components as needed.
   • Coordinate M3.2.R Ancillary documents as needed.
5. Communication and Reporting:
   • Escalate delays in timelines and flag identified risks to the CMC GRL and/or appropriate leadership.
   • Coordinate internal document review and sign-off.

Preferred Qualifications

• Education: Postgraduate in Pharmacy/Science
• Experience: Minimum 0-1 years in leading independently in the Regulatory Affairs function in a reputed Pharmaceutical Organization.
• Skills: Excellent oral and written English communication skills, good conceptual and reasoning skills, attention to detail.

How to Apply

If you are ready to embark on a journey of regulatory excellence with Pfizer,

APPLY ONLINE