Regulatory Affairs

Hiring for a Well-Established MNC Pharma 2nd Largest in the Industry!

Division :

Department

Qualification

Experience

Work Location

No of Positions Vacant

Key Responsibilities :

PRE and POST APPROVALS :

1. Component with EU-Filing requirements with respect to Module 2 & 3 ability to independently and correctly review technical documents related to Quality Module

2. Well versed with EU- Regulatory guidance and Processes (i.e., Ability to understand and interpret technical expectations as per applicable ICH & EMEA guidelines)

3. Clear Knowledge of basic aspects of a formulation (primarily pharmaceutical development along with general analytical aspects) for effective review of R&D documents

4. Should be aware of post approval variation requirements in EU markets. Should have basic QA knowledge to enable correct review of plant related documents

5. Review of TTD documents such as Specifications (API, FP, Excipients, packing materials), Product development report, stability protocols, dissolution protocols, packing plan etc.

6. Maintenance of status (Customer status, DCP-MRP & Renewal timetable, Variations, Batch sizes, shelf life, CEP & Audit status etc.)

Interested candidates can share their profiles or contact us for more details:

7032376834