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Amgen Inc
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Regulatory Affairs Sr Associate (Site)

Regulatory Affairs Sr Associate (Site)

Amgen Inc

2 - 7 years

3 - 7 Lacs

hyderabad

Posted:13 hours ago| Platform:

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Skills Required

pharmaceutical fda regulatory regulatory affairs cmc webi usfda documentation anda regulatory compliance gmp sap bo pharmacovigilance ra ich ctd quality assurance business objects qms drug regulatory affairs dmf web intelligence

Work Mode

Work from Office

Job Type

Full Time

Job Description

The Senior Associate in Regulatory Affairs at Amgen plays an important role in ensuring that the company's products meet and maintain regulatory standards. They assist in preparing submissions for regulatory agencies, keep updated on changes in regulatory legislation, and guide various teams within the company to ensure compliance with applicable regulations.

R egulatory 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 maintenance of 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, and Device Regulatory, Operations, Quality, and Supply Chain teams on strategies and activities impacting licensed products.

Roles & Responsibilities:

Key responsibilities of the Regulatory Affairs Sr Associate include:

- Tracks license status to ensure all are current and effective.
- Communicates requirements 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.
- Interfaces with State Board of Pharmacy ( BoP ) and/or Department of Health ( DoH ).
- Complete s required annual notifications to FDA

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a type of person with these qualifications.

Basic Qualifications:

Masters degree OR
Bachelors degree and 2 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
Associates degree and 6 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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Regulatory Affairs Sr Associate (Site)