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Cmc Manager

4 years
Not Disclosed
10 Sept. 8, 2025
Job Description
Job Type: Full Time Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Team Leader – Regulatory Affairs


Main Purpose of Role

  • Lead and supervise a team of 2+ professionals within the Regulatory Affairs Sub-Function.

  • Act as the first-level manager for a work team comprising professionals, technical staff, and/or administrative staff.

  • Focus on mentoring, coaching, and coordinating team activities.

  • Role typically does not include direct budget or hire/fire authority.


Key Responsibilities

  • Supervise professionals in preparing and directing product registration submissions, progress reports, supplements, amendments, and periodic experience reports.

  • Interact with regulatory agencies to expedite approval of pending registrations.

  • Serve as regulatory liaison throughout the product lifecycle.

  • Contribute to product plan development, regulatory strategy, risk management, and Chemistry Manufacturing Controls (CMC).

  • Ensure timely approval of new drugs, biologics, or medical devices, and support continued approval of marketed products.

  • Represent the Regulatory Affairs function to internal teams (marketing, research) and external regulatory agencies.

  • Advise development and/or marketing teams on:

    • Manufacturing changes

    • Line extensions

    • Technical labeling

    • Appropriate regulations and interpretations


Qualifications

Education

  • Bachelor’s Degree in a relevant scientific field (preferred)
    OR

  • Associate’s Degree with approximately 13 years of relevant experience

Experience

  • Minimum 4 years of experience in Regulatory Affairs or related function