Regulatory Affairs Manager Amgen Technology Private Limited

3.0 - 6.0 years

3 - 12 Lacs

Hyderabad, Telangana, India

On-site

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 to ensure consistent and compliant submissions. Contribute to projects focused on applying 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 initiatives and data standards. Monitor industry trends and guidance to maintain up-to-date knowledge of 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 Master's degree with 3 years of directly related experience OR Bachelor's degree with 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 experience in digitalization, automation, and software development Background in manufacturing, process development, quality control, or quality assurance Hands-on experience with Veeva Vault platforms and regulatory technology solutions

Posted 1 week ago

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