Regulatory Affairs Manager III - UK
An internationally known biotechnology company has an opening for a position as a Regulatory Affairs Manager III at their UK-based office. The company has a strong reputation for developing innovative therapies for neurological diseases and employs approximately 7,000 people worldwide. The Regulatory Affairs Manager will contribute to the development and implementation of EU regional clinical and pre-clinical regulatory strategy for products post MAA approval. This is a contract position.
- Leading the planning, coordination, and preparation of regulatory submissions and label development, supporting the EU Regulatory Lead for products post MAA approval.
- Identifying and assessing regulatory risks associated with assigned projects and overall product development.
- Assisting in defining strategies to mitigate risks.
- Representing regulatory on project teams for assigned projects.
- Representing the company for defined projects (as appropriate) with local and regional regulatory authorities, contractors, and corporate partners.
Skills and Requirements:
- BA/BS/University degree is required, Life/Health Sciences preferred.
- Minimum of 5 years pharmaceutical/biotechnology industry experience with technical management experience.
- Minimum of 2 years in Regulatory Sciences.
- Some EU regulatory experience managing submissions preferred.
- Experience in interpretation of regulations, guidelines, and policy statements.
- Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements.
- 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 Emily Oakley-Keenan at +44 2038542469 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing 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.
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