Head of Regulatory Affairs - UK/Ireland
A global top 10 pharmaceutical company has an exciting Head of Regulatory Affairs position available at their site in Berkshire. The company specialise in a variety of therapeutic areas with market leading treatments and an excellent pipeline of drugs in development.
- Working cross functionally with Medical Affairs, Quality, Pharmacovigilance and Customer Facing Compliance to ensure the quality and compliance of all products and its subcontractors and a sustainable provision of service to our customers.
- Developing strategic partnerships with the MCO Global Business Units to understand their priorities and align regulatory objectives of the MCO regulatory team to support the business.
- Directly managing the Operations Regulatory Department and lead the team in its programme with regards to strategy and tactics to ensure effective and timely approval of all marketing authorisations.
- Advising, initiating, problem solving and participating actively in any new product developments or opportunities that evolve across the MCO portfolios.
Skills and Requirements:
- Education: Physician, Pharmacist, Veterinarian or Life Sciences Graduate.
- Proven and extensive Regulatory Affairs experience.
- Good knowledge in local and EU regulatory legislation, procedures and guidelines governing pharmaceutical products.
- Brexit preparation expertise, future changes in regulatory methods and approaches.
- Ability to demonstrate diplomacy and assertive skills in dealing with internal and external partners.
- Strong interpersonal skills to motivate the team and liaise effectively with internal and external contacts.
- Change management skills, managing change and the effect within the team/department.
- 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 with 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.