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Head Regulatory Affairs

14.00 to 16.00 Years   Mumbai City   26 Oct, 2020
Abbott Healthcare
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryRetail
Functional AreaSBU Head / CEO / Director
EmploymentTypeFull-time

Job Description

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 EducationM.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.,

Keyskills :
continuous improvement facilitationrisk managementmedical devicesline extensionscorporate liaisonregulatory affairsstrategy implementationproduct registration

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