Sr. Associate Regulatory Affairs

Amgen; Hyderabad; On-site; INR 1,200,000 - 2,200,000; Full time

Job summary

Amgen in Hyderabad, India, is expanding the ROOTS2 Regulatory CMC submission team to support product development and global registrations. The role focuses on leading CMC submissions, coordinating with cross-functional experts, and maintaining timelines for device and pharmaceutical products.

The candidate should have a Life Science degree with 5–9 years in regulatory CMC, strong project management, and experience with regulatory submissions.

Qualifications

• Bachelor’s degree in Life Science or related field.
• 5–9 years of experience in manufacture, QA/QC, or regulatory CMC.
• Experience in regulatory submissions for CMC, devices, or IVD preferred.
• Strong project management and communication skills.

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, IDE/PSA/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

Skills

Regulatory affairs

CMC regulatory submissions

Project coordination

Communication skills

Education

Bachelor’s degree in Life Science

Tools

Veeva Vault

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.

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, Regulatory Optimization of Tactical and Strategic Support (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, including leading projects, based upon their experience level. Additional job responsibilities include:

• 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