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AGM Regulatory Affairs - ROW
Talent Linked Consultancy
posted 1hr ago
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Flexible timing
Key skills for the job
Job Description
Qualification: B.Pharm / M.Pharma / MSc.
JobDescription:
- Must be worked as a Corporate RA/Regulatory head for last 3 to 5 years with a team size handled of 2 to 3 Direct reportees dossier planning, submission and Approvals for ROW, LatAm, Meena, CIS, Africa, Asia, DCGI etc.
- Must have experience in Dossier Review , compilation , submission, Query response, Variation strategy and Annual updation of drug product CTD for SVP injectable mainly for Emerging markets (Submission required: Not less than 25 CTD )
- Good communication and drafting skills while Client/MOH interaction.
- Must have developed the registration pathways based on regulatory strategies for future growth in terms of budgeting, planning and implementation .
- Must have network of Regulatory authority , consultant, CRO for BA/BE studies, PvG including ADR/PSUR and DCGI submission.
- Must have undertaken the BA/BE studies , ADR and PSUR studies for Emerging market independently.
- Must be skilled in critical thinking, planning and scheduling of projects , oral/verbal communication, GTD/Delegation and Advance excel tracking etc
ThresholdRequirement in the Job role (additional but not mandatory)
- Experience of in house sourcing dossier submissions COS (Certificate of Suitability)
- 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
- Completion of BA/BE studies for tabs.
- Registration of 70 to 100 products for ROW markets.
- DCGI submission of 2 to 4 products and approval of 2 to 3 products (already submitted)
- Planning, unrolling and successfully meeting the relevant milestones of Annual RA plan.
Employment Type: Full Time, Permanent
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Flexible timing
Alternate Saturday off
No travel
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Associate / Sr Associate / Assistant Manager - Communications
3-5 Yrs
Mumbai
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