Associate Director Regulatory Affairs

A spectacular opportunity has arisen for an Associate Director Regulatory Affairs for a Global Biotech in South East England. The company specialises in neurological conditions and puts a great emphasis on teamwork and delivering biological products.

Job Responsibilities

• Work in close partnership with relevant affiliate staff; lead local regulatory activities for the affiliate to contribute to early stage pipeline and marketed product changes as appropriate
• Pre- and post-approval of European labelling activities together with contributing to the European Regulatory Strategy (input to early and late phase projects, marketed products)
• Maintain country and international stakeholder communication and relationship plans and optimize working relationships
• Maintain current awareness/information pertaining to local affiliate requirements; gain regulatory intelligence within the country and contribute to Central Regulatory Intelligence function
• Ideally, have been involved in BREXIT preparations, have a good understanding of the implications on a local Regulatory environment and ability to prepare the local business
• Operational delivery and compliance with local in-country regulatory responsibilities (including budget and people / vendor management) including but not limited to ensuring audit / inspection readiness
• Attend relevant meetings with key international functions and represent local regulatory in-country needs: Regulatory Affairs, Commercial, Market Access and Drug Safety
• Act as the company liaison for Horizon Scanning activities

Skills and Requirements

• Must have degree in science-related field
• 5-6 years working experience in the Regulatory field of the (bio)pharmaceutical industry
• Versed in MS-Office, web applications, Regulatory relevant databases (e.g. intelligence tools such as Cortellis), as well as in electronic Document Management Systems and electronic review systems
• Excellent communication skills

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 0203 869 2329 or upload your CV on our website - www.proclinical.com/send-cv

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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