Manager Regulatory Affairs

3 weeks ago


Mumbai, Maharashtra, India Abbott Laboratories Full time

MAIN PURPOSE OF ROLE

  • Specialist professional individual contributor with comprehensive knowledge in the area of Regulatory Affairs.
  • Ability to execute highly complex or specialized projects.
  • Adapts precedent and may make significant departures from traditional approaches to develop solutions.

MAIN RESPONSIBILITIES

  • As the Specialist in the Regulatory Affairs Sub-Function, considered as highly experienced and knowledgeable resource within the organization in 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 labeling, appropriate regulations and interpretations.

QUALIFICATIONS

Education

  • Associates Degree (± 13 years)

Experience/Background

  • Minimum 7 years


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