Regulatory Affairs Manager – Amgen – in Hyderabad, Apply Now!
Looking to advance your career in biotechnology regulatory affairs? Amgen, a global leader in human therapeutics, is hiring a Regulatory Affairs Manager in Hyderabad, India. This role focuses on Chemistry, Manufacturing and Controls (CMC) submissions and global regulatory strategies for Amgen products. Discover how you can contribute to life-saving innovations while working with a world-renowned biotech company.
Job Details:
- Job ID: R-207691
- Location: India – Hyderabad
- Work Location Type: On Site
- Category: Regulatory
Job Description:
Amgen’s Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) team is seeking a Regulatory Affairs Manager to join its ROOTS2 team in India. The selected candidate will play a crucial role in facilitating product development and global registration by developing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout the product lifecycle.
Key Responsibilities:
- Lead submission for annual reports, facility registrations, facility renewals, and product renewals
- Potential to oversee or manage staff
- Act as a primary point of contact for specific submission execution or annual reporting tasks, including but not limited to, developing, documenting and maintaining process documents, training and onboarding new staff, and/or coordinating with impacted cross functional teams as Regulatory Affairs
- Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions
- Preparing and/or over seeing preparation of submission content plans for CMC submissions including, CMC IND/CTAs and amendments, Investigational Device Exemption (IDE)/Performance Study Application (PSA)/ Clinical Investigation Application (CIA), new marketing applications, facility registration and renewals, post‑market supplements/variations, product renewals, Module 3 baselines, and annual report/notifications
- Coordination, preparation, collection and/or legalization of CMC country specific documents
- Document and archive CMC and/or Device submissions and related communications in the document management system as Regulatory Affairs
- Initiate and maintain CMC product and/or Device timelines at the direction of product lead
- Interface with the regulatory operations team
- Train staff on select CMC procedures and systems
- Provide report status of activities and projects to teams and department
- Participate in cross-functional special project teams
Basic Qualifications:
- Doctorate degree OR
- Master’s degree and 5 years of minimum experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR required for Regulatory Affairs.
- Bachelor’s degree and 7 years of minimum experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
Preferred Qualifications:
- BS degree in Life Science preferred for Regulatory Affairs.
- Experience managing or hovering staff members
- Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development
- Experience in IVD, Device or Combination Product regulatory submission process
- Regulatory CMC specific knowledge and experience as Regulatory Affairs
- Mature project management and organizational skills
- Strong and effective oral and written communication skills
- Experience in Veeva Vault platforms
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