RA Specialist CMC

Location Beerse, Arrondissement Turnhout, Antwerp, Flanders
Discipline: Biotechnology
Contact name: Aimee Brenner

Contact email: a.brenner@panda-int.com
Job ref: 13687
Published: 25 days ago

I am urgently recruiting for a motivated Regulatory Affairs Specialist (CMC) to join a leading Biotech in Beerse, Belgium (partly remote).

The primary responsibility is to support the post-approval CMC regulatory activities related to small molecules in all global markets.

Responsibilities:

  • Support teams, including representing CMCRA in meetings and provide direction on the interpretation and application of global CMC regulations and guidelines for CMC changes including country specific requirements
  • define regulatory strategy
  • write CMC variation dossiers and coordinate responses to Health Authorities (HA)
  • renewal variations (as requested), development of product-specific regulatory strategy documents
  • technical review and approval reports and other source documents
  • change controls and other related duties as assigned


Profile

  • Direct and significant CMC regulatory experience with post approval amendments and variation dossiers for small molecules worldwide.
  • Strong knowledge of global/worldwide regulatory guidelines and regulations is required.
  • Experience in supporting Health Authority meetings (FDA & APAC is a plus, EMA is a must) preferred.
  • Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required.
  • Strong interpersonal, teamwork, leadership, conflict management, fast learner and negotiation skills are essential. The candidate must be able to motivate people within a matrix team environment as an individual contributor, decision maker, and leader.
  • Excellent knowledge of English (written & spoken).

Practicalities

  • Duration: End of the year (extension possible)
  • Start date: ASAP
  • Remote work possible, max once a month on site (Beerse).

Interested?

Please apply with your CV. For further information, please contact Aimee Brenner at +31 (0)20 20 44 502 or by email at a.brenner@panda-int.com

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