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.
- 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 email@example.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.