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Amgen Inc
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Regulatory Affairs Manager

Regulatory Affairs Manager

Amgen Inc

3 - 8 years

7 - 10 Lacs

hyderabad

Posted:20 hours ago| Platform:

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Skills Required

software development quality control process development veeva quality assurance ectd regulatory submissions regulatory documentation anda dossier preparation ich ra ctd regulatory affairs cmc life sciences drug regulatory affairs dmf vault actd

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Summary:
Amgen is seeking a Manager, Regulatory Affairs CMC Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a meaningful impact on regulatory efficiency and compliance.

Join us in revolutionizing regulatory submissions through cutting-edge data automation!

Key Responsibilities:

Support the implementation of automation and digital tools to streamline regulatory CMC documentation and submission workflows.
Assist in developing standardized templates and structured data formats for consistent and compliant submissions.
Contribute to projects focused on the application of AI and structured content/data management (SCDM) for regulatory use cases.
Coordinate with cross-functional teams, including Process Development, Quality, and Regulatory Affairs, to ensure alignment on automation and data standards.
Monitor industry trends and guidance to maintain up-to-date knowledge on digital and regulatory innovations.
Support the design and deployment of automated solutions for data extraction, conversion, and integration with regulatory platforms.
Participate in training activities to expand internal capabilities in digital tools and regulatory data automation.
Assist in regulatory interactions related to digital transformation, ensuring preparedness for engagement on evolving standards.

Basic Qualifications:

Doctorate degree OR

Masters degree and 3 years of directly related experience OR

Bachelors degree and 5 years of directly related experience

Experience managing and leading a team in a regulatory or compliance environment

Preferred Qualifications:

Degree in life sciences, digital or data science, biochemistry, or chemistry

Experience leading global regulatory CMC submissions with knowledge of ICH guidance and global requirements

Background or basic experience in digitalization, automation, software development

Background in manufacturing, process development, quality control, or quality assurance

Hands-on experience with Veeva Vault platforms and regulatory technology solutions.

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Amgen Inc

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Regulatory Affairs Manager