Regulatory Affairs Manager

An internationally known biotechnology company is recruiting a Regulatory Affairs Manager to their UK-based office. The company has a strong reputation for developing innovative therapies for neurological diseases and employs approximately 7,000 people worldwide. This is an exciting opportunity to work with a prestigious establishment and bolster a career in the regulatory field.

Job Responsibilities:

• Leading the planning, coordination and preparation of regulatory submissions and label development, supporting the EU Regulatory Lead for products in development and/or post MAA approval.
• Identify and assess regulatory risks associated with assigned projects and overall product development. Assist in defining strategies to mitigate risks.
• Represent regulatory on project teams for assigned projects.
• Represent the company for defined projects (as appropriate) with local and regional regulatory authorities, contractors and corporate partners.

Skills and Requirements:

• BA/BS/University degree required; Life/Health Sciences preferred.
• Minimum 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.

To Apply:

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 Peter Duvall at +44 03 078 9542 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.

Proclinical Staffing is an equal opportunity employer.

#LI-116788626_PD1

#RegulatoryAffairs