Regulatory Affairs Director Europe

Highly Competitive
  1. Contract
  2. Senior/Director & VP
  3. Switzerland
Zug, Switzerland
Posting date: 19 Jan 2024
58418

Proclinical are recruiting for a Regulatory Affairs Director Europe to join a biotech organisation. This role is on a contract basis and is located in Zug.

Responsibilities:

  • You will integrate the European regulatory, legal, scientific/medical and business perspectives to accomplish the optimal regulatory results rendering to company goals.
  • Responsible for translating tactics into operational objectives and targets.
  • Guarantee that the organisation follows through to accomplish high-quality implementation of plans.
  • Offer direction for maximising prospects in projects such as development and life cycle.
  • Converse with global regulatory affairs colleagues in a timely manner.
  • The ideal candidate will watch, anticipate and acts on trends and alterations in the European regulatory setting which might have an impact on the business.
  • Partake and add value to the authoring of scientific papers for regulatory purposes.
  • Implement deliberations with EMA aligned with the tactics and offer tactical directions.
  • Other duties may be assigned.

Key Skills and Requirements:

  • Demonstrable experience in regulatory affairs in a biopharmaceutical organisation.
  • Educated to an advanced degree level though a PharmD or PhD would be ideal.
  • Familiarity within oncology.
  • Ideally acquainted with CDx.
  • Capable of partaking in scientific papers developed for regulatory purposes.
  • Analytical capabilities.
  • Communication skills both verbally and in writing.
  • Formed credibility and respect throughout past exposure with regulatory peers and authorities.
  • A background in forming partnerships and cross-functional collaborations.
  • Demonstrated leadership abilities.
  • Works well in a team with a customer-focused mindset.
  • Able to resolve issues.
  • A high attention to detail with the capacity to work well independently.
  • Project management familiarity.

If you are having difficulty in applying or if you have any questions, please contact Dracen Black at d.black@proclinical.com.

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

Proclinical Staffing is an equal opportunity employer.

#Regulatory

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