Manager Regulatory Affairs Site CMC [Ireland]

 

Job Description

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.

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.

$ads={1}

Additional Job Description

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

Preferred Experience and Education:

• CMC - specific regulatory knowledge & experience.
• Doctorate degree
  OR Master’s degree and 3 years of directly related experience
  OR Bachelor’s degree and 5 years of directly related experience
  OR Associate’s degree and 10 years of directly related experience
• Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry
• Regulatory CMC experience

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney diseases, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

$ads={2}

 

.