Regulatory Affairs Manager
An exciting opportunity has arisen for a Regulatory Affairs Manager to join a leading and growing Speciality Immunotherapeutic Company. This British based company is enthusiastic to bring on a bright and dynamic new member into their team, to help solidify their stance in the pharmaceutical market.
- Taking on the role as the regulatory lead
- Ensuring the registration and maintenance of all vaccines across Europe and internationally.
- Reporting to the Head of Corporate Regulatory Affairs
- Manage a small team of regulatory professionals
- Provide strategic regulatory input into the business
- Ensure business compliance and ensure smooth delivery of regulatory submissions
- 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
- Extensive national/MRP licence experience and experience with IDMP and CMC
- Have a rounded regulatory knowledge.
- 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 David Nixon at 02030789544 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.