Regulatory Affairs Manager

39 minutes ago

Hyderabad, Telangana, India Amgen Inc Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. The Regulatory Compliance team is a part of RA CMC and is seeking to expand its capacity in India . The Regulatory Compliance team performs assessment of operational changes for regulatory reportability and maintains state and federal licenses for Amgen products across phases of development, modality, and countries.

The team member will be responsible for maintaining U.S. state and federal commercial product licenses and will collaborate with Global CMC, Site CMC, Device Regulatory, Operations, Quality, and Supply Chain teams on strategies and activities impacting licensed products.

Roles & Responsibilities:

Key responsibilities of the Regulatory Affairs Manager include:

    • Conducts periodic assessments of licenses / facilities and ensure s business practices comply with current regulations and statutes.

  • Evaluates new and existing regulations to maintain up-to-date compliance.

  • Communicates requirements to internal Amgen functional teams.

  • Obtains supplemental documentation from internal and external partners.

  • Prepar es , reviews, and submits license applications and renewals.

  • Maintains all State Licensing documentation, submissions, and interactions with State Authorities.

  • Interfaces with State Board of Pharmacy ( BoP ) and/or Department of Health ( DoH ).

  • Complete s required annual notifications to U.S. FDA

  • Obtains DUNS and FEI numbers for new U . S . sites, as required

  • Processes Financial obligations relating to fee payment.

  • Identifies and implements process improvements for the state licensing process

  • Coaches and supp orts junior regulatory staffs career development

*What we expect of you*

We are all different, yet we all use our unique contributions to serve patients. The successful candidate will have the following qualifications:

Basic Qualifications:

  • Doctorate degree OR
  • Masters degree and 3 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
  • Bachelors degree and 5 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry

Preferred Qualifications:

  • Degree in Life Science discipline
  • Regulatory CMC specific knowledge & experience
  • Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry
  • Working knowledge of US state and/or federal licensing requirements

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