ProClinical is seeking an Associate Director, Global Labeling, for a global biotechnology company at the forefront of advanced therapies to treat a range of devastating rare and orphan diseases. The Associate Director will be responsible for the development and maintenance of the Target Product Profiles, Company Core Datasheets (CCDS), and regional labeling to lead the strategic development and subsequent submission, launch, and post approval maintenance of clinical and globally marketed products. The Associate Director facilitates the generation of new and revised product labeling with key local and global disciplines as well as external alliance partners and serves as the expert for the regulatory history for labeling communications with FDA and global health authorities. The individual in this position will also support the maintenance of the Migalastat Amenability Website to ensure compliance across applicable regions.
The Associate Director must have Regulatory Affairs experience in pre-and post market labeling, experience building labeling processes and teams, possess advanced project management, document management and publishing skills, including use of the Microsoft Office Suite, Adobe Acrobat and a recognized Project Management application. A B.S. or M.S. degree is required (advanced degree preferred) with at least 8-10 years of experience.
- Leads efforts to create, modify, and review labeling documents, including core data sheet, prescribing information, patient labeling, and packaging/artwork content for use with attention to competitive positioning
- Co-ordinates response to labeling-related questions from authorities and convenes labeling working group meetings to reach content consensus with technical experts
- Prepares presentations and trains other departments and outside speakers
- Responsive to business goals offering creative and compliant solutions while ensuring absolute regulatory integrity and consistency in labeling activities and communications
- Works collaboratively with colleagues in the Regulatory Affairs, Medical, Legal, and Commercial team members during labeling development and reviews
- Provides upon request analysis of competitor labeling in the relevant therapeutic area
- Responsible for continuous quality and compliance throughout the packaging labeling process
- Member on project teams and regulatory sub-teams, as appropriate
- Contribute to the development and implementation of Corporate and Department procedures and policies for the development of labeling.
Skills and Requirements:
- BS or MS in scientific discipline or equivalent required.
- Advanced degree and/or RAC certification preferred
- 8-10 years of regulatory affairs experience with drugs and/or biologics
- At least 5 years' experience in pre and post market labelling development and review
- Extensive knowledge of global regulations, guidance documents, and initiatives related to labeling requirements
- Excellent interpersonal skills and written and oral communications skills
- Excellent organizational, communication, and time management skills needed to manage multiple ongoing projects simultaneously
- Must be able to innovate, analyze, and solve problems with minimal supervisory input
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 Mike Froggatt on +1 646 768 9727 or upload your resume 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.