Pfizer Pharma Associate Job Openings – Apply Online Now
Job Title: Associate II – Reg CMC Strategy, SI LCM
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Location: India – Chennai
Time Type: Full time
Posted On: Posted 2 Days Ago
Job Requisition ID: 4910407
Responsibility
- 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.
Attributes:
- 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.
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