Regulatory Manager - Global CMC

Highly Competitive
  1. Permanent
  2. CMC
  3. Belgium
Brussels, Belgium
Posting date: 19 Nov 2020
34243

Proclinical are partnered with a house-hold pharmaceutical business, who are looking to further strengthen their CMC division with a new Regulatory Manager.

You will be supporting all Regulatory CMC Activities across a vaccines portfolio for an initial duration of 12 months.

Skills and Requirements

  • Direct and significant regulatory experience with vaccines and in CMC documentation preparation for late phase INDs and IMPDs, BLAs and MAAs for vaccines highly preferred.
  • Strong knowledge of EU and FDA regulations is required, experience with other markets is added value.
  • Experience in supporting Health Authority meetings (FDA, EMA and national agencies) 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 manage and motivate people within a matrix team environment and as an individual contributor, decision maker, and lead

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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