Regulatory Affairs Manager - CMC

Amgen • Thousand Oaks, CA

1d • $112,744 - $152,536

About The Position

The Regulatory Affairs Manager - CMC is responsible for strategy and execution of site-specific preparation of CMC post-market supplements and facility registrations. The role interfaces with site functions to coordinate regulatory filings, identify issues that may affect regulatory strategy or activity, and provide deviation impact assessments in partnership with CMC Product teams and the CMC Region representative.

As the Regulatory CMC voice for product teams, the manager defines minimum filing requirements for post-approval programs; develops regulatory strategy through MASP and/or GIRS; develops post-approval variations; maintains applications and product compliance; supports change management; responds to agency questions; and facilitates agency interactions. The role also works with development, operations, and commercial functions to align global regulatory strategies, timing, execution, and plans; contributes to the PDT’s Variation Master Plan; and participates in cross-functional teams.

Requirements

• Doctorate degree; or a master’s degree and 2 years of Regulatory Affairs experience; or a bachelor’s degree and 4 years of Regulatory Affairs experience; or an associate’s degree and 8 years of Regulatory Affairs experience; or a high school diploma/GED and 10 years of Regulatory Affairs experience.

Nice To Haves

• Degree in a life sciences discipline, or equivalent relevant experience.
• Experience in Regulatory CMC within the pharmaceutical or biotechnology industry.
• Working knowledge of ICH guidelines and current GMP and GCP requirements.
• Experience preparing and compiling regulatory dossiers in accordance with ICH guidelines and Common Technical Document (CTD) structure.
• Experience in pharmaceutical or biotechnology manufacturing, Quality Control (QC), or Quality Assurance (QA).

Responsibilities

• Develop strategy and execute site-specific preparation of CMC post-market supplements and facility registrations.
• Coordinate preparation of regulatory filings with site functions.
• Identify issues and factors that may implicate regulatory strategy or activity.
• Provide deviation impact assessments with input from CMC Product teams and the CMC Region representative.
• Define minimum regulatory filing requirements for post-approval programs.
• Provide regulatory strategy through development of MASP and/or GIRS.
• Develop post-approval variations.
• Maintain applications, including Annual Reports, Distribution Reports, and Annual Stability updates.
• Maintain product compliance through appropriate regulatory filings, activities, and regulatory commitments.
• Support Change Management activities as needed.
• Respond to regulatory agency questions.
• Facilitate agency interactions, including meeting preparation, meetings, and briefing documents.
• Liaise with development, operations, and commercial functions to align global regulatory strategies, timing, execution, and plans.
• Contribute to the PDT’s Variation Master Plan as required.
• Participate as an active member of cross-functional teams.

Benefits

• Retirement and Savings Plan with generous company contributions.
• Group medical, dental, and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Work/life balance and career development opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed