Sr. Associate Regulatory Affairs
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 the 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:
Lead submission for annual reports, facility registrations, facility renewals, and product renewals.
Interact with authors/reviewers and subject matter experts regarding the delivery of CMC documents required for regulatory submissions.
Prepare 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.
Annual report/notifications.
Coordinate, prepare, collect, and/or legalize 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 the product lead.
Interface with the regulatory operations team.
Train staff on select CMC procedures and systems.
Provide status reports of activities and projects to teams and departments.
Participate in cross-functional special project teams.
Basic Qualifications:
Master’s degree OR
Bachelor’s degree and 1-2 years of experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
Associate’s degree and 6 years of experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
High school diploma / GED and 8 years of experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry.
Preferred Qualifications:
BS degree in Life Science.
Experience in manufacturing, 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 with Veeva Vault platforms.
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