Regulatory Affairs Manager (Site)
Regulatory Affairs Manager (Site)
India - Hyderabad APLICAR AHORARegulatory 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. TheRegulatory Compliance teamperforms 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 andensures business practices comply with current regulations and statutes.
Evaluates new and existing regulations to maintain up-to-date compliance.
Communicatesrequirements to internal Amgen functional teams.
Obtains supplemental documentation from internal and external partners.
Prepares, reviews, and submits license applications and renewals.
Maintains all State Licensing documentation, submissions, and interactions with State Authorities.
Interfaceswith State Board of Pharmacy (BoP) and/or Department of Health (DoH).
Completes 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 supports junior regulatory staff’s 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
Master’s degree and 3 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
Bachelor’s 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
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now
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