Regulatory Affairs Director

A leading biotechnology company is seeking to hire a Regulatory Affairs Director for their office in Uxbridge. The organisation discovers, invents, and develops biopharmaceutical medicines, specialising in assisting pharmaceutical and biotechnology companies. This is an exciting opportunity to work with a unique company with an award-winning approach and dynamic environment.

Job Responsibilities:

• Lead, manage and develop EU regulatory team members by serving as a resource for EU knowledge for the global regulatory and development teams and for the reporting EU regulatory team.
• Build the representation of the company's EU regulatory function to EMA and EU National Agencies, as well as Alliance partners as required.
• Assist Development teams and Regulatory senior management in developing strategies that are EU-appropriate and take advantage of EU regulatory systems and processes, in particular the application of innovative regulatory pathways to our development products.
• Provide leadership on MAA related process and strategy to ensure timely product approvals with competitively differentiated labelling.
• Direct execution of clinical trial applications for assigned programs and provide leadership for team members responsible.
• As needed, support activity with Business Partners to ensure the EU regulatory strategy
• Monitor emerging legislation and guidance in the EU and contribute to ensuring company- level awareness and compliance (where appropriate).
• Provide support to department liaisons with their project specific communications and issues, including Agency meetings, responses to CTA challenges and CRO oversight as required.
• Report to the Vice President of EU Regulatory Affairs and ensure emerging issues are flagged in a timely manner.

Skills and Requirements:

• Advanced degree in a scientific discipline.
• 10+ years regulatory experience with a focus on supporting products through clinical development.
• Experience of managing and developing staff members essential.
• Proven track record of supporting EU Clinical Trial Applications through approval and study start up.
• Experience in dealings with the EMA (scientific advice, orphan designation, PIPs).
• Experience of bringing a product through EU approval is a distinct advantage.
• Ability to negotiate and concisely express clear positions to stakeholders at all levels.
• Experience of directly working with national regulatory agencies and leading agency meetings face to face.
• 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 Alex Czuprynski at +44 03 869 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.

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