Labeling Manager

Proclinical is working with a Regulatory Affairs service provider that is seeking a Labelling Manager to be based in North America, spending 50% in New York and 50% in Princeton on a contract basis.

The purpose of this position is to prepare global labelling components (CCDS/CCSI/RSI), US and EU labelling (prescribing information, patient information and other required labelling components) documents for developmental, mature and marketed products to obtain company and/or agency approval. Development of labelling for these products is based on study results, coordination of labelling review and approval throughout the company, preparation of labelling components for submission to regulatory agencies, and participation in labelling negotiations with agencies resulting in product approvals or labelling updates. This position also includes subject matter expertise in specific labelling regulations (e.g., US, EU, and review of local labelling to assure compliance with corporate labelling.

The Global Labelling Manager will be responsible for the labelling of a portfolio of marketed products and products under development.

Job Responsibilities:

• Support cross-functional teams as a labelling expert and contribute to the definition of global regulatory labelling strategies and to the preparation of submission dossiers or responses to Health Authorities
• For R&D projects (new product or association, extension of indication or formulation, Rx-to-OTC switches etc.), Regional Life Cycle Managements (LCM) Activities
• For the maintenance and compliance of existing Marketing Authorizations (be a member of Response Teams within procedures such as European Arbitration/referrals, PSUR or paediatric work-sharing, PRAC questions, signal detection etc
• Prepare corporate labelling documents (Core Data Sheet or Core Safety Information), US and EU Summary of Product Characteristics and patient/consumer leaflets for projects and marketed products within the framework of regulatory submissions to obtain new Marketing Authorizations or to update existing Marketing Authorizations.
• Assess development study reports, pharmacovigilance data (post-marketing), study data and any other scientific reports.
• Manage regulatory requisites pertaining to labelling and implies interface with International Health Agencies.
• Lead a multidisciplinary labelling working group (Global Regulatory Affairs, Global Pharmacovigilance, Global Medical Affairs, Legal, Communication, preclinical and CMC etc.), the labelling working group is responsible for labelling proposals and the preparation of supportive documents and dossiers for labelling modifications
• Coordinate the presentation of Core labelling content or labelling proposals to the Senior Executive Management via a Labelling Review Committee.
• Uses expertise in specific labelling regulations (e.g., US, EU, Non-prescription labelling) to be a source of information for the department when specific questions or topics arise.
• Responsible for providing Regulatory Inputs to Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs)

Skills and Requirements:

• Degree in science or medicine or Pharm D.
• Minimum of 8 years of experience in pharmaceutical industry with minimum of 5 years' experience in global labelling.

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 Jay Foster on +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.