Job Title: Senior Associate, Regulatory Affairs
Location: Hyderabad, India
Work Location Type: On-site
Date Posted: January 20, 2025
Category: Regulatory
Company Overview:
Amgen is a leading biotechnology company specializing in human therapeutics. For over 40 years, the company has driven innovation in the field of medicine, helping millions of patients. As a Fortune 500 company, Amgen is dedicated to advancing the practice of medicine and supporting those battling serious illnesses through scientific discovery and entrepreneurship.
Job Description:
Amgen’s Regulatory Affairs, Chemistry, Manufacturing, and Controls (RA CMC) team facilitates product development and global registration by executing regulatory strategies and managing interactions with regulatory agencies across product lifecycles. The ROOTS2 team, responsible for supporting CMC submission execution, is expanding in India. This role will involve supporting regulatory submissions for Amgen’s products at various stages of development across multiple modalities and countries.
The staff member will interact with Amgen’s Global, Site, Biosimilars, and/or Device RA CMC teams, contributing to strategic decisions and executing specific regulatory activities. They will take responsibility for leading projects and providing product support, depending on their experience level.
Key Responsibilities:
Lead Regulatory Submissions:
Oversee submissions for annual reports, facility registrations, renewals, and product renewals.
Collaboration and Coordination:
Work with authors, reviewers, and subject matter experts to prepare and deliver CMC documents for regulatory submissions.
Preparation of Submission Content Plans:
Develop content plans for CMC submissions such as IND/CTAs, amendments, new marketing applications, post-market supplements/variations, product renewals, and annual reports/notifications.
Document Management:
Coordinate and collect CMC country-specific documents and manage the document archive for regulatory submissions.
Timeline Management:
Maintain and initiate product timelines in line with the direction of the product lead.
Team Interaction and Reporting:
Interface with regulatory operations and other teams, providing regular status updates on project activities.
Training & Development:
Train staff on select CMC procedures and systems.
Cross-Functional Collaboration:
Participate in cross-functional teams for special projects related to CMC submissions.
Qualifications:
Basic Qualifications:
Master’s degree OR
Bachelor’s degree with 1-2 years of experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
Associate’s degree with 6 years of experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
High school diploma/GED with 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
Specific knowledge and experience in Regulatory CMC
Mature project management and organizational skills
Strong oral and written communication skills
Experience in Veeva Vault platforms
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