Sr. Associate Regulatory Affairs

Biopharma Careers; Hyderabad; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Amgen in Hyderabad, India, is expanding its ROOTS2 Regulatory CMC team to support product development and global registrations. The role involves coordinating regulatory submissions, document preparation, and cross-functional collaboration to ensure timely timelines.

The candidate should have 5–9 years in regulatory CMC, strong communication, and project management skills, with experience in Life Science contexts and familiarity with Veeva Vault platforms.

Qualifications

• Bachelor’s degree with 5–9 years in manufacture, QA/QC, or regulatory CMC in the pharma/biotech industry.
• BS in Life Science preferred; experience in regulatory submissions for IVD/Device/Combination products.

Responsibilities

• Lead submission for annual reports, facility registrations, renewals, and product renewals.
• Coordinate with authors, reviewers and SMEs for CMC/Device submission documents.
• Prepare submission content plans for CMC submissions including IND/CTAs, IDE/PSA/CIA, and variations.
• Coordinate collection and localization of CMC country-specific documents.
• Document and archive CMC submissions and communications in DMS.
• Initiate and maintain CMC timelines under product lead guidance.
• Interface with regulatory operations team; train staff on procedures.
• Provide status reports to teams and participate in cross-functional projects.

Skills

Communication skills

Project management

Regulatory language

Education

Bachelor’s degree

BS in Life Science

Tools

Veeva Vault

Job description

Career Category

Regulatory

Job Description

Job Description:

Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness.

Regulatory 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. Amgen’s CMC submission execution team, R egulatory O ptimization o f T actical and S trategic S upport (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC and/or Device submission execution for Amgen products across phases of development, modality and countries.

The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, based upon their experience level.

Additional job responsibilities

• Lead submission for annual reports, facility registrations, facility renewals, and product renewals
• Interact with authors/reviewers and subject matter experts with respect to delivery of CMC and/or Device documents required for regulatory submissions
• Preparing 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 submissions and related communications in the document management system
• 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 procedures and systems
• Provide report status of activities and projects to teams and department
• Participate in cross-functional special project teams

Basic Qualifications

• Bachelor’s degree and 5-9 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry

Preferred Qualifications

• BS degree in Life Science
• 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
• Mature project management and organizational skills
• Strong and effective oral and written communication skills
• Experience in Veeva Vault platforms

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