Senior Manager - Global Regulatory Affairs Labelling

Proclinical is working with an emerging biotechnology company that is seeking a Senior Manager, Global RA Labelling to be based in Berkshire on a permanent basis. In this newly created position reporting to the Associate Director of Regulatory Affairs for Advertising, Promotion and Labelling, the Senior Manager/Manager will support building and refining the company's global labelling processes and capabilities and provide labelling strategy and operational support for assigned company products.

Job Responsibilities:

• Represent Global Labelling on product-specific Global Regulatory Teams and other cross-functional product, development, and product safety teams as appropriate.
• Create, revise and maintain Company Core Data Sheets (CCDS) for the company's products.
• Develop labelling strategies and Target Label Profiles
• Keep up-to-date on emerging clinical and other data, product safety, changes in manufacturing, and completion of post-marketing commitments and requirements for company products that may trigger changes to the CCDS and regional or local labelling.
• Provide strategic guidance to Core Labelling Teams regarding new and revised labelling regulations, competitor labelling, and labelling trends.
• Assess and communicate impact on the company's products
• Lead and/or provide support with development and maintenance of regional labelling that aligns with the CCDS and meets the requirements of health authorities.
• Lead and/or assist with preparation of responses to labelling-related queries from health authorities.
• Coordinate labelling activities (e.g. labelling supplements, new labelling development) with internal and external alliance partners as required.
• Partner with Regulatory Technology and Operations and Supply Chain to ensure submission-ready labelling components comply with regulatory requirements. Assist with preparation of submissions to health authorities, as needed.
• Track data sources supporting labelling claims, history of labelling negotiations and changes, and reasons for differences in local labelling.
• Support the growth of the Global Labelling function and help design/build systems and processes.

Skills and Requirements:

• BS/BA degree (science or related discipline preferred); graduate degree desirable.
• Minimum of 5-7 years of professional experience in the biopharmaceutical industry in fields of Regulatory Affairs, Pharmacovigilance, and/or Medical Writing/Communications.
• Minimum of 4 years of experience in Regulatory Affairs in a Labelling role.
• Familiarity with US, EU and Global regulations, standards and guidance documents related to labelling of pharmaceutical products
• Must be detail-oriented and able to multi-task and manage multiple projects.
• Skilled in written and verbal communications.

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 call David Nixon on +44 203 078 9544 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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