Functions as support for GRS-CMC to perform the following activities (under supervision) for Nitrosamine assessment:
Step 1 Assessment for Nitrosamine risk
Step 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.
Qualification & Experience
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.