Manager Regulatory Affairs | Abbott (EPD) | Mumbai

Job Description

Main Purpose of Role:

  • Summarize the main purpose of the role.
  • Experienced professional individual contributor that works under limited supervision.
  • Applies subject matter knowledge in the area of Regulatory Affairs.
  • Requires capacity to apply skills/knowledge within the context of specific needs or requirements.

Main Responsibilities:

  • As an Experienced professional in the Regulatory Affairs Sub-Function, possesses well-developed skills in directing the development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports.
  • Interacts with regulatory agencies to expedite approval of pending registration.
  • Serves as regulatory liaison throughout the product lifecycle.
  • Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, and 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.

 

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