Regulatory Affairs Consultant Biologics

Proclinical is advertising a vacancy for a Regulatory Affairs Consultant Biologics with a pharmaceutical company. The applicant will support this company's Switzerland based team by working with them on their biologic product.

Job Responsibilities:

• Leading and coordinating timely and high-quality preparations of all necessary supporting documentation by internal or external experts for EU license renewals, EU variations (except CMC-related variations), and PSUR submissions.
• Managing the interaction with RA colleagues in Country organizations.
• Acting as a point of contact for agency interaction
• Overseeing project management/lead responsibilities.
• Providing support during Health Authority interactions.

Skills and Requirements:

• Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline).
• 3 - 5 years' experience in regulatory consulting with biologicals, life cycle management
• Broad knowledge of global regulatory requirements
• Experience with biological entities from early development through life cycle management.
• Proven track record in leading in-direct teams with cross functional scope.
• Strong communication skills to internal and external audiences.
• 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 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 Jay Foster at +44 203 752 0309 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.

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