Abbott Job Opening For MSc / Phd / B-Pharma/ M-Pharma - Regulatory Affairs

Abbott Job Opening For MSc / Phd / B-Pharma/ M-Pharma - Regulatory Affairs

Qualification: Msc, B-pharma, M-pharma, Ph.d

Location : Mumbai 

Experience : 14-16 Years 

MAIN PURPOSE OF THIS ROLE :

• 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.

MAIN 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.

Minimum Education: 

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.

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