Sr. Manager, Site Reg Affairs

4 weeks ago

Dublin, Ireland Amgen Full time

Group Purpose

To facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.

Job Summary

The RA CMC Sr. Mgr. supports ADL Site and is responsible for providing guidance and leadership to the ADL Site CMC Team, as needed.

The RA CMC Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for products manufactured at or planned for the specific site. The CMC site team interfaces with the site (R&D and operations authors) coordinate preparation of regulatory filings, identification of issues and factors that may implicate a regulatory strategy or activity. The CMC site team are members of CMC product teams. The CMC Site team is also responsible for coordination of site-specific change control regulatory assessments with input from the CMC Product teams and the CMC Region representative. The CMC site team is the key RA CMC representative on product deviation investigation teams.

Key Activities

Responsible for the strategy and execution of the site-specific aspects of the preparation of CMC investigational product amendments and post-market supplements, CMC sections for annual reports and annual reports of minor changes for specific products; acts as key RA CMC representative on product deviation investigation teams.

Key activities include but are not limited to:

  • Support sites in the execution of change control regulatory assessment and strategy proposal for all markets.

  • Support sites with CTA/MA evaluations and establishment registration submissions.

  • Support sites with variations processes management on special projects.

  • Manage site related CMC processes, policies and best practices.

  • Promotes continuous improvement of processes.

  • Develop and maintain relationships with other functions in development, operations, and commercial to ensure alignment on project/product processes and best practices.

  • Oversee timeline and tracking system information to ensure consistency in planning Site RA CMC deliverables.

  • Serve as an expert advisor to site functional teams, as needed.

  • Support company initiatives and large-scale RA CMC projects as requested.

Knowledge and Skills

RA CMC knowledge and, preferably, experience.

Basic understanding drug development phases.

Ability to develop solutions to technical and/or organizational issues to improve performance and productivity.

Knowledge on Manufacturing and Operations experience desirable.

Ability to work independently.

Basic knowledge on biologics regulations, GMP’s, QMS principles with Change control/ Deviations.

Acquainted with electronic QMS systems and RA systems.

Education & Experience (Basic)

Doctorate degree and 2 years of directly related experience OR

Master’s degree and 6 years of directly related experience OR

Bachelor’s degree and 8 years of directly related experience OR

Associate’s degree and 10 years of directly related experience OR

High school diploma / GED and 12 years of directly related experience

Education & Experience (Preferred)

Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry

Regulatory CMC experience

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