- Review of the CTD/ACTD/Country specific dossiers as per the requirement for ROW market.
- Coordinating with different departments for relevant documents required for dossiers/Query/FDA
- Reviewing of the relevant documents like DMF, Analytical reports, Specification, Process Validation Protocol, Report, BMR, COA, PDR, Stability data.
- Review of artworks related with dossier.
- Handling queries from the health authority.
- Coordinate with TP/LL site / supply chain/marketing team

7.Guide to junior team members

Executive Regulatory Affairs 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

📌 Executive Regulatory Affairs (Navi Mumbai)
🏢 Kilitch Drugs India
📍 Navi Mumbai