Regulatory Affairs Job at Amgen
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Regulatory Affairs Job at Amgen – Life Sciences Apply Now!

Sr. Associate Regulatory Affairs

India – Hyderabad

JOB ID: R-205853

LOCATION: India – Hyderabad

WORK LOCATION TYPE:
On Site

DATE POSTED: Feb. 03, 2025

CATEGORY: Regulatory

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 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 documents required for regulatory submissions
  • Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, 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 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:

  • Master’s degree OR
  • Bachelor’s degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
  • Associate’s degree and 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
  • High school diploma / GED and 8 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
  • 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

APPLY ONLINE HERE

Keywords: Sr. Associate Regulatory Affairs, Amgen, Regulatory Affairs, CMC, Pharmaceutical, Biotechnology. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like TwitterTelegramFacebook and Instagram. Regulatory Affairs Job at Amgen – Life Sciences Apply Now!

Shekhar
Shekhar Suman is the Co-founder of BioTecNika Info Labs Pvt. Ltd. He is an Entrepreneur, Writer, Public Speaker, and a Motivational Coach. In his career, he has mentored more than 100,000+ students toward success in the Biopharma Industry. He heads the BioTecNika Group, which comprises BioTecNika.com, BioTecNika.org, and Rasayanika.com. An avid reader and listener who is passionate about BioSciences. Today Biotecnika is India's largest Biotech Career portal, with over 5 Million subscribers from academia & Industry. It's ranked among the top 50 websites worldwide in the Biology category.

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