Senior Manager, Regulatory Affairs
A leading pharmaceutical client is looking to hire a Senior Manager for their Regulatory Affairs team in UK. The international company specialises in various therapy areas including oncology and neurology. This is an amazing opportunity to bring your experience and knowledge to a company that effectively contributes to medicine.
- Acting as EU Regulatory Lead for an early phase compound, inputting into Global Strategy
- Leading the preparation of Orphan Drug Applications, PIPs and CTAs
- Close interactions with US-based GRL's and cross functional teams globally
- Supporting EU RA activities - specifically two compounds in Phase III
- Managing registration and regulatory support for commercial and development projects worldwide.
- Supporting EU and global clinical trials.
- Supporting development and implementation of regulatory strategies to facilitate the progress of programs through all phases of development, under the supervision of GRA leadership.
- Through the performance of risk assessments, working with GRA leadership to identify and communicate potential risks associated with strategy scenarios to the multi-disciplinary team.
- Acting as regulatory representative at meetings with business partners and regulatory agencies.
Skills and Requirements
- Background in EU Regulatory activities, specifically with Clinical Trials
- Regulatory strategy experience and strong strategic thinking
- Ideally, experience with EU Scientific Advice/PIPs or Orphan Drugs, as well as some experience in Neuroscience therapy area
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Alex Czuprynski at 0203 869 2329 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.