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| 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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