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Regulatory CMC Associate Director

Job description

About Your New Employer

  • One of the leading multinational companies in developing and commercializing innovative pharmaceutical products.
  • Changing peoples' and patients' lives every few seconds worldwide.
  • Fantastic learning opportunities and a chance to lead a Regulatory team to support operations in Europe.

About Your New Job

  • You will be working closely with BIL Quality Assurance, Quality Control, and Manufacturing groups to assure the relevant product and regulatory expectations are met.
  • You will be reporting directly to the Senior Director of the EU Regulatory CMC group.
  • You will act as the primary regulatory CMC contact with contract manufacturing organizations (CMOs) based in Europe.
  • Timely compilation and management of all necessary documentation for regulatory submissions. Ensure submissions are of high quality; that content and format of regulatory submissions comply with application regulations and guidelines governing the development, licensure, and marketing of drugs and/or biologics.
  • Provide regulatory CMC support for impact assessment to change control, deviation, and inspection management. 
  • Coordinate and track regulatory commitments related to the site.
  • Lead and/or participate in cross-functional project teams and work effectively with multiple disciplines and personalities.
  • Demonstrate initiative and have the ability to work both independently and collaboratively in a team structure and in a global organization. 

What Skills You Need

  • Extensive experience in Regulatory Chemistry Manufacturing and Controls (CMC).
  • Knowledge and experience in biologics and/or pharmaceuticals.
  • Technical expertise in the areas of responsibility.
  • Effective problem-solving mindset.
  • Strong understanding of regulatory affairs submissions.
  • Management skills and the ability to prioritize multiple tasks.

What’s on Offer

Strong competitive salary along with many benefits.

What’s Next​

For a confidential discussion on this or any other current job opportunity please contact Barbara Szatkowska on 086 796 1534 / barbara@sigmar.ie

Why Apply Through Sigmar?

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