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Associate Director of Regulatory Affairs CMC

Job description

Do you want to work for a company that develops best in class therapies for a worldwide customer base?

My client is looking for an Associate Director of Regulatory Affairs CMC to join their ever-growing team on a 12-month contract.

About Your New Employer

  • Leading Biopharmaceutical company that is based in Co. Cork.
  • 20+ years of experience developing innovative class therapies for people throughout the world.
  • They focus on rare conditions where they believe they make a meaningful impact.

About Your New Job

  • You will work closely with Quality Assurance, Quality Control & Manufacturing to assure the relevant product & regulatory expectations are met.
  • Management of all necessary documentation for regulatory submissions- ensuring the highest quality content.
  • Provide CMC support for impact assessment to change control, deviations & inspection management.
  • Track regulatory commitments related to the site.
  • Participate/lead cross-functional project teams.

What Skills You Need

  • Level 8 in the relevant field.
  • Knowledge & experience in biologics and/or pharmaceuticals.
  • Technical expertise.
  • Strong understanding of regulatory affairs submissions.
  • Management experience.

What’s On Offer

  • 12-month contract.
  • Negotiable on salary – flexible for the right candidate.
  • Monthly pay.
  • 25 days annual leave.
  • Endless progression opportunities.
  • An opportunity to work within a leading Biopharmaceutical company.

What’s next?

Apply now by clicking the “Apply Now" button or call me Meggan on 021 235 9144 / mtully@Sigmar.ie

I look forward to your application!

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