Job Description

Manager /Sr Manager - Regulatory Affairs (International Markets)

Position - Assistant Manager/Manager -Regulatory Department

Exe - 5 years

Qualification - M. Pham/ M.B.A Must

Pref. Industry - Pharma (Manufacturing/Exports ONLY)

Joining - Within One Month

No of Positions - 2 (1 for ROW Market & 1 for EU Market).

Location - Mumbai

Job description

1)Candidate should have worked at least 5 to 6 years in a top 10 pharma companies.

2)Hands on Experience of Regulatory Norms for ROW/PIC's /EU markets

3)Preparing dossiers for ROW /PIC's market based on ICH CTD / ACTD/EUCTD format as per the country requirement.

4)Registration of Pharmaceuticals products in International markets.

5)Good knowledge of EU/ ROW CTD & ACTD formats.

6)Well versed with ICH Guidelines.

7)Responding to queries raised by consultants and MOH of the above regions.

8) Candidates should have

excellent command on English and communication skills

.

Desired Candidate

Candidate from top 10 pharma company only Not Too many changes in Job.
Job Types: Full-time, Permanent

Benefits:

Health insurance Paid time off Provident Fund
Application Question(s):

What is your current location in Mumbai? Describe your current Designation and current role in a few words. Current CTC Expected CTC What is your Notice period at your current organisation?
Work Location: In person