Sr. Associate Regulatory Affairs

About The Role ::

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. Amgens 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:

Masters degree OR

Bachelors degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry

Associates 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