"Discover How to Land a Pharmaceutical Regulatory Affairs Associate Role at Pfizer!"

Pfizer Pharma Associate Job Openings – Apply Online Now

Job Title: Associate II – Reg CMC Strategy, SI LCM


Location: India – Chennai

Time Type: Full time

Posted On: Posted 2 Days Ago

Job Requisition ID: 4910407


  • Nitrosamine Assessment: Functions as support for GRS-CMC to perform activities (under supervision) related to Nitrosamine assessment, including:
    • Step 1 Assessment for Nitrosamine risk
    • Step 2 Confirmatory testing
  • Technical Document Review: Responsible for effective review and providing timely feedback to the GRL/RRL/CRL on technical documents as needed.
  • Remediation Planning: Coordinates with the GRL/RRL/CRLs to support the preparation, review, and finalization of Global Regulatory Strategy Documents (GRSDs).
  • Submission Execution: Authors required CTD sections for filing supplements/variations, ensuring effective data presentation and quality according to the finalized GRSD supporting GRS CMC.
  • Data Alignment: Supports the data alignment team related to RPS.
  • Regulatory Risks: Identifies and assesses regulatory risks associated with assigned projects and communicates them to the team for quick mitigation.
  • Work Environment: Works under supervision, following established procedures and general instructions.
  • Regulations & Guidelines: Stays knowledgeable about current regulations/guidelines and correlates them with assigned projects.

Qualifications / Skills

  • Education: Bachelor’s or Master’s degree in Science/Pharmacy preferred.
  • Experience: Minimum 3 years of independent work in the Regulatory Affairs function at a reputed pharmaceutical organization, with major experience in handling post-approval changes for health authorities.


  • Strong English communication skills (both verbal and written)
  • Good interpersonal and negotiation skills
  • Strong conceptual and reasoning skills
  • Attention to detail

Technical Skills:

  • Knowledge of regulatory requirements for post-approval changes for various global regulatory agencies, particularly USFDA and EMA & other EU health authorities.
  • Solid understanding of ICH Quality Guidelines.
  • Familiarity with sterile injectable manufacturing and regulatory data requirements for submission.
  • Knowledge of general standards, processes, and policies of the pharmaceutical industry.

Work Location Assignment: Flexible

To apply for the position, please visit the original notification.

Keywords: Pfizer, pharmaceutical company, healthcare solutions, Regulatory Affairs, pharmaceutical organization, post-approval changes, ICH Quality Guidelines, apply for job. Pfizer Pharma Associate Job Openings – Apply Online Now. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.


Please enter your comment!
Please enter your name here