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Regulatory Affairs Manager CMC

  • Job reference: 932826
  • Location: Dún Laoghaire, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 18/11/2020

Orion Group Sciences are looking for a Regulatory Affairs Manager CMC for our Multinational Pharmaceutical Client based in the South Dublin area on an initial 18-month contract with the potential to extend.

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.
Organization CMC, Device Regulatory, Pediatrics and Biosimilars

Job Summary

  • 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, 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
  • CMC- specific regulatory knowledge & experience

Education & Experience (Preferred)

  • Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry
  • Regulatory CMC 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 and10 years of directly related experience
  • OR High school diploma / GED and12 years of directly related experience

For more information on this role, call Denise Cagney on +44 (0) 203 994 4695 or email denise.cagney@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number: 932826


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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