Work as Regulatory Affairs Head @ Abbott
Post : Head Regulatory Affairs
• 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.
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
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
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube