Senior Consultant at Strike-It-Rite Managment Consultants
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Vice President - Regulatory Affairs - Biotech (15-25 yrs)
1 RA support to Biotech R&D pipeline and due diligence (product and facility)
2 Supervise/effect timely filings/approval of dossier
3 Regulatory compliance of Wockhardt's assets in Biotechnology R&D pipeline.
4 Represent Wockhardt in various Biotech forums and agency meetings.
5 Requirement mapping versus regulations, in alignment with chosen business model. Feasibility and risk-benefit comparison.
6 Regulatory intelligence and screening for optimum strategy. Market analysis and forecast factored in future risks and preparative plan.
7 Mitigate risks by mapping prospective developments against regulations, influencing stakeholders and driving change.
JOB SPECIFIC COMPETENCIES I.E. THE KNOWLEDGE, SKILLS AND ATTITUDE NEEDED TO PERFORM YOUR JOB (Click on the link to view definitions and proficiency levels)
1 Sound knowledge of Biotechnology and Regulatory Science
2 Thorough understanding of regulations and laws governing pharmaceutical business in the country of interest
3 Capability to envisage issues and resolve them to maintain the flow.
4 Establish simplified systems to maintain flow through creating regulatory database and knowledge management
JOB COMPLEXITIES I.E. WHAT IT TAKES TO BE SUCCESSFUL IN YOUR JOB.
Engagement with the internal and external stakeholders including regulatory agencies.
KEY MEASURES OF SUCCESS I.E. METRICS THAT WOULD HELP IN DEFINING AND MEASURING PROGRESS
Technical issues resolved in time in the Biotech business unit - Voice of Customer - Turn around time on questions, filing defect free dossiers culminating into timely approval/product launch.
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