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CMC Manager

CMC Manager

Abbottmumbai, India
1 day ago
Job description

MAIN PURPOSE OF ROLE

  • Leads / supervises a team of more than 2 professionals within the Regulatory Affairs Sub-Function.
  • First level manager of a work team that may comprise professionals, technical and / or administrative staff.
  • Typically without budget or hire / fire authority.
  • Focuses on mentoring, coaching, and coordination.

MAIN RESPONSIBILITIES

  • As the Team Leader (Professionals) of the Regulatory Affairs Sub-Function, supervises professionals 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

    Education Level

    Major / Field of Study

    Or

    Education Level

    Associates Degree (± 13 years)

    Experience / Background

    Experience

    Experience Details

    Minimum 4 years

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    Manager • mumbai, India