Director Site Regulatory CMC

4 days ago

Cork, Cork, Ireland Elusav Recruitment Full time

2 days ago Be among the first 25 applicants

Direct message the job poster from Elusav Recruitment

Technical Recruitment Specialist - Industrial Recruitment - Data Centers - Pharmaceutical - SemiConductor - Qualified Engineer (BEng,MSc)

Elusav recruitment have an exciting opportunity for an Associate Director/Director, Regulatory CMC with a leading Global Biopharmaceutical in Cork, Ireland.

As the Associate Director you will act as the primary regulatory CMC contact at the company site comprising end to end manufacturing of biologicals (drug substance, drug product, QC testing and packaging operations).

Responsibilities:

  • Working on site for at least 2 days a week is expected.
  • Working closely with the company's Quality assurance, Quality Control and Manufacturing groups to ensure the relevant product and regulatory expectations are met;
  • Manage a small team of regulatory CMC professionals at the site. Brand the excellent work of the regulatory team at site meetings and at global regulatory meetings.
  • Primary regulatory CMC contact with contract manufacturing organizations (CMOs) based in Europe, as required.
  • Lead global marketing authorisations, renewals and post-approval changes for biological products, drug-device combination products and/or small molecules.
  • This role includes the compilation of all necessary documentation for global regulatory submissions.
  • Ensure submissions and responses to regulatory questions are of high quality and right first time; that content and format of regulatory submissions comply with application regulations and guidance governing the development, licensure and marketing of drugs, biologics and /or gene therapy medicinal products.
  • Lead regulatory CMC support for impact assessment to change control, deviation and cGMP inspection readiness at the site.
  • Coordinate and track regulatory commitments related to drug substance and drug product technology transfers.
  • 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 independently and collaboratively in a team structure and in a global organization.

Requirements:

  • Minimum requirement is for a bachelor's degree in a pharmacy, biological discipline, chemistry, or molecular biology or other science.
  • Minimum of 8 years of Regulatory Affairs, CMC experience.
  • Proven experience in a leadership role with strong management skills and business acumen.
  • Experience with people management preferred.
  • Understanding of drug development, technology transfers and working under accelerated timelines.
  • Outstanding interpersonal and communication (written and verbal) skills are required. Strong writing and editing skills for technical documentation.
  • Proficient with computer and standard software programs.
  • Able to travel 10%.

Contract:

If you would like to learn more about the vacancy, apply now, or contact Brendan Mullins on +353 61 527 150 or Bmullins@elusav.com

Seniority level
  • Director
Employment type
  • Full-time
Job function
  • Science
  • Pharmaceutical Manufacturing
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