General Manager - Regulatory Affairs - Pharma

We have career opportunity with leading pharma company as General Manager RA.

Must Requirements in Job role ( Knowledge/Experience/Qualification/Salary).

1. Must be worked as a Corporate RA/regulatory head of pharma or RA company for last 3 to 5 years with a team size handled of 2 to 3 Direct reportees for CT, dossier submission and PvG with team size of 8-10

2. Must have experience in Development, compilation, submission and Annual updation of drug product CTD for SVP injectables mainly for Europe, Australia and other SRA markets (Submission required : 10-20 CTD)

3. Must have developed the registration pathways based on regulatory strategies for future growth in terms of budgeting, planning and implementation.

4. Must have network of Regulatory authority, consultant, CRO for BA/BE studies, PvG including ADR/PSUR and DCGI submission.

5. Must have undertaken the BA/BE studies, ADR and PSUR studies for EU and other market independently.

6. Must have settled the various agreement related to CT, PvG and as SME for EU product development tie ups.

7. Must be skilled in critical thinking, planning and scheduling of projects, oral/verbal communication, GTD/Delegation and Advance excel tracking etc.

8. Qualification: B.Pharm /M.Pharm.

9. Experience: 12 to 18 yrs.

Threshold Requirement in the Job role ( additional but not mandatory)

1. Submissions to regions like Europe (DCP), MRP & NP, in eCTD & NeES formats as per the requirement.

2. Experience of in house & sourcing dossier submissions & COS (Certificate of Suitability)

3. Experience in Registering 80-100 dossier per year in immediate past companies into emerging markets.

Expected Output ( Quantitative/Qualitative) from the role in current or next 1 year

1. Completion of BA/BE studies for tabs.

2. Submission of 20 to 30 Dossiers for SRA countries.

3. Registration of 70 to 100 products for ROW markets.

4. DCGI submission of 2 to 4 products and approval of 2 to 3 products( already submitted)

5. Taking on board right RA team.

6. Planning, unrolling and successfully meeting the relevant milestones of Annual RA plan.