Regulatory Affairs CMC Sr. Manager, Site Lead

Regulatory Affairs CMC Sr. Manager, Site Lead

Amgen

Dublin, Ireland

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

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 of IND annual reports and annual reports of minor changes for specific products; acts as key RA CMC representative on product deviation investigation teams.

Knowledge and Skills

  • CMC- specific regulatory knowledge & experience.

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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© EuroJobsites 2018

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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