Regulatory Affairs Director Europe

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