- Functions as support for GRS-CMC to perform the following activities (under supervision) for Nitrosamine assessment:Step 1 Assessment for Nitrosamine riskStep 2 Confirmatory testing
- Responsible for effective review and providing timely feedback to the GRL/RRL/CRL on technical documents (on a need basis).
- Remediation Planning: Effective coordination with the GRL/RRL/CRLs, and extend support as needed towards preparation, review and finalization of Global Regulatory Strategy Documents (GRSDs).
- Submission Execution: Author required CTD sections for filing of supplements /variations,ensuring effective data presentation and quality, as per the finalized GRSD supporting GRS CMC.
- Support the data alignment team related to RPS
- Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks.
- Works under supervision.
- Performs all assignments using established procedures and general instructions on the process.
- Remains knowledgeable about current regulations / guidelines and correlates in the assigned projects.
- Preferred Education:
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Associate II – Reg CMC Strategy, SI LCM - chennai, India - Pfizer
Description
Responsibility:
QUALIFICATIONS / SKILLS:
Bachelors or Master in Science / Pharmacy
· Preferred Experience:
Minimum 3 Years in working independently in the Regulatory Affairs function in a reputed Pharmaceutical Organization with major experience in handling post approval changes to health authorities.
· Preferred Attributes:
Good English communication skills (both verbal and written). Good interpersonal and negotiation skills.
Good conceptual and reasoning skills. Attention to details.
· Technical Skills:
o Regulatory requirements of post approval changes for various global regulatory agencies especially
USFDA and EMA & other EU health Authorities.
o Sound understanding ICH Quality Guidelines.
o Sterile injectable manufacturing and regulatory data requirements for submission.
o Knowledge on general standards, processes and policies of Pharmaceutical Industry.
Work Location Assignment: FlexiblePfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
