Regulatory Manager

A vacancy has arisen for a Regulatory Manager with an internationally renowned biotechnology company, based in their office in the UK. The organisation is known for their work discovering, inventing, and developing biopharmaceutical medicines in relation to science, manufacturing, and commercialisation. This vacancy is an exciting opportunity to work in a start-up environment with a company that has been consistently ranked as a 'Top Employer' in pharmaceutical and biotechnology companies.

Job Responsibilities:

• Assisting Development teams and Regulatory management in developing strategies that are EU-appropriate and taking advantage of EU regulatory systems and processes.
• Providing leadership on both late and early-stage clinical development related process and strategy to ensure timely study conduct end to end.
• Assisting clinical teams in study start-up and maintenance activities by leading all associated regulatory activities, including but not limited to, submissions, addressing agency queries, and managing compliance issues.
• Providing leadership on MAA related process and strategy to ensure timely product approvals with competitively differentiated labelling.
• Supporting activity with Business Partners to ensure the EU regulatory strategy meets business objectives.
• Monitoring emerging legislation and guidance in the EU and contributing to ensuring company-level awareness and compliance (where appropriate).
• Building the representation of the company's EU regulatory function to EMA and EU National Agencies, as well as partners as required.
• Further building the company's regulatory profile in the EU and serving as a resource for EU knowledge for the global regulatory and development teams.
• Conducting those activities as deemed necessary under the leadership of the Director of Regulatory Affairs to support program progression.

Skills and Requirements:

• Advanced degree in a scientific discipline.
• 5+ years regulatory experience with a focus on supporting products through clinical development.
• Experience of life-cycle management of approved products in the centralised procedure a distinct advantage.
• Experience in dealings with the EMA (scientific advice, orphan designation, PIPs) an advantage.
• Proven track record of supporting EU Clinical Trial Applications through approval and study start up.
• 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 Robert Esposito at +44 203 761 5702 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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