Category: Legal / Contracts
Industry: Pharmaceutical & Life Sciences
Position: Regulatory Affairs Manager
Job type: Full Time, Permanent
Salary: ₹ 10,00,000 - 16,00,000 P.A.
Experience: 9 - 14 years
Roles and Responsibilities
Note: Required Candidate from Regulated Market and Pharmaceutical Background only (US/UK/EUROPE etc).
1. Manage and lead Regulatory Affair Department in handling different regulatory authority requirement.
2. Responsible in preparation, review and approval of complete dossiers as CTD or eCTD to Regulatory Authorities.
3. Authorized to handle Inquiries from Regulatory Authorities related to company and product registration.
4. Submission of Registration Dossiers in ROW,Semi-Regulatory and Emerging market as of now.
5. To ensure timelines are met for the project submissions including dossier, query response, variations, reports, renewal procedures, and all other regulatory applications
6. Involved in Design and approval of product Artwork, SPC and PIL.
7. To impart training to various functions in-line with current regulatory requirement of various countries at regular intervals to make the team effective.
8. Coordinating and preparing for Regulatory and QP Audits, Quality Management System set-up, Communication & information / Data Management Skills, Team/Project Leadership & Management
9. Assisting QA/QC and R&D departments for the preparation documents as per international requirements.
10. Strategy planning for the Regulatory filings Regulatory personal recruitments and training Work distribution and review Strategy and planning for the regulatory dossier filing.
11. Reviewing all technical documents like DMFs, Stability data and protocol, COAs, process validation, analytical method validation and media fill validation, HVAC validation, SOP, STP/Spec. as per the requirement of the dossier preparation and registration.
12. Ensuring the transfer and implementation of all the approved documents to Plant, QA, QC and customers
Desired Candidate Profile
Perks and Benefits
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