General Manager - Regulatory Affairs - ROW Market - Pharma

General Manager - Regulatory Affairs - ROW Market - Leading Pharmaceutical Company (20-22 yrs)

Designation: GM - DRA - ROW

Location : R&D, Mumbai

Exp : 20- 22 years

Qualification: PhD, M. Pharma

Age : Not more than 45 years

Roles and responsibilities :-

1. Overall responsibility of DRA-ROW.

2. Planning and executing of dossiers as per the schedule finalized with marketing

3. Timely dispatches of queries ( within 15days from the day of receipt)

4. Co-ordination with Marketing / Commercial/ PPIC / other departments within Advent for matters related to DRA-ROW.

5. Training of DRA personnel w.r.t understanding of Regulatory guidelines.

6. Submission of monthly MIS.

7. Responsible for handling of DRA sample Store.

8. Responsible for submission to Pharmexcil for fees reimbursement.