1. Review of the CTD/ACTD/Country specific dossiers as per the requirement for ROW market.
2. Coordinating with different departments for relevant documents required for dossiers/Query/FDA
3. Reviewing of the relevant documents like DMF, Analytical reports, Specification, Process Validation Protocol, Report, BMR, COA, PDR, Stability data.
4. Review of artworks related with dossier.
5. Handling queries from the health authority.
6. Coordinate with TP/LL site / supply chain/marketing team
7.Guide to junior team members
Executive Regulatory Affairs job description should include these common skills and qualifications:
B.Pharm/M.Pharm with 3-5 years of experience in ROW market
Understanding of both legal and scientific matters
Ability to grasp concepts quickly and to assimilate and evaluate data
Analytical and problem-solving skills
Team-working skills
Integrity and a professional approach to work
Good written and oral communication skills
Good computer skills, particularly in relation to using databases and familiarity with word, excel
Job Type: Full-time
Benefits:
- Paid sick time
- Paid time off
- Provident Fund
Ability to commute/relocate:
- Navi Mumbai, Maharashtra: Reliably commute or planning to relocate before starting work (Required)
Experience:
- 2year: 1 year (Preferred)
Work Location: In person
