Abbott India Limited is a subsidiary of Abbott Laboratories, USA, a global, iversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company now employs approximately 70,000 people and markets its products in 130 countries worldwide.
Post : Head Regulatory Affairs
Job Description
• Manages teams within the Regulatory Affairs Sub-Function.
• Focus is on policy and strategy implementation and control rather than development.
• Typically handles short-term operational/tactical responsibilities.
• As the Manager of the Regulatory Affairs Sub-Function, oversees the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
• Interacts with regulatory agency to expedite approval of pending registration.
• Serves as regulatory liaison throughout product lifecycle.
• Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
• Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
• Serves as regulatory representative to marketing, research teams and regulatory agencies.
• Advises development and/or marketing teams on manufacturing changes, line extensions, technical labelling, appropriate regulations and interpretations.
Candidate Profile
M.Sc / B.Pharm / M.Pharm / Ph.D in Pharmacy having relevant experience of around 14 - 16 years in regulatory affairs mainly for emerging markets. Having exposure to US / EU will be an added advantage
Additional Information
Qualification : M.Sc / B.Pharm / M.Pharm / Ph.D
Location : Mumbai
Experience : 14 - 16 years
Job ID : 30962421
Functional Area : Regulatory Affairs
End Date : 20th November, 2020
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