Work as Global Regulatory Services Head at Bristol-Myers Squibb

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Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Post : Global Regulatory Services Head

Job Description
The key objective of this role is to drive Regulatory department performance in order to deliver timely regulatory submissions (paper / electronic) and approvals, while promoting integrity, transparency and proactive communication of expectations to stakeholders, for regulatory activities like, but not restricted to
• New drugs/biologics, subsequent new drugs/biologics, new/additional dosage strengths/forms, manufacturing site, import license registration/renewal registration; withdrawals, etc. for commercialized products
• Post-approval variations/amendments like CMC, CCDS (i.e. package inserts) and labelling, manufacturing site, company registered address etc. for commercialized products
• Study protocol, protocol amendments, test license, investigation sites, periodic study reports etc. for clinical trials
• Health Authority commitments and queries

Candidate Profile
• Degree in Pharmacy or in other Life Sciences,
• 5-10 years of core functional regulatory knowledge an of which 3- 5 years of experience in leading the country regulatory team
• Exposure to international regulatory environment and capability to adapt the regulatory organization and implement appropriate plans.
• Proven experience and ability to manage people and cross functional groups
• Demonstrated track record of developing teams and creating working systems and processes
• Ability to negotiate
• Fluency in English
• Willingness to travel (approx.20% of working time, to Delhi)

Additional Information
Experience :
5-10 years
Qualification : B.Pharm
Location : Mumbai
Industry Type : Pharma / Healthcare/ Clinical research
Functional Area : Regulatory Services
End Date : 15th January, 2020

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