Director, Global Regulatory Affairs Labeling

Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.

The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.

Job Summary (Primary function)

The Dir, Global Labeling Regulatory Affairs leads the labeling function within Regulatory Affairs and will be accountable for delivering high quality and compliant labeling for products across our portfolio. The Dir holds both a strategic and operational role, focused on the development and implementation of an efficient, robust, compliant and global labelling process. This includes products under development and maintenance of marketed products. The Dir works in collaboration with the cross-functional development team to define appropriate labeling strategies and ensure regulatory requirements are met to deliver timely approvals.

Essential Functions of the Job (Key responsibilities)

• Partner effectively across the organization including, but not limited to, R&D, Pharmacovigilance, Manufacturing, Supply Chain, and Commercial.
• Support product teams during labeling discussions with regulatory authorities; liaise with health authorities, as needed (e.g. telephone contacts, teleconferences, meetings, submissions). Establish and maintain a system for the appropriate retrieval, distribution and archive of product labeling to support internal and external requirements and support audits/inspections.
• Responsible for coordinating the preparation and review of product specific information for regulatory submissions.
• Provide regulatory labeling support to cross-functional project teams.
• Evaluate and define regulatory labeling requirements needed for approval and marketing in targeted regions.
• Advise teams on the regulations, guidance, and industry best practices related to product labeling.
• Manage/organize the labelling committee and maintain oversight of company core data sheet (CCDS).
• Define appropriate regulatory labeling strategies and recommends labeling language for submission to the targeted regions.
• Establish and implement the labeling function for development and post-approval phases, including development of relevant systems, processes, and procedures.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Strong knowledge of regulations/guidelines governing development of pharmaceutical product labeling; experience in working with international regulatory agencies; working knowledge of systems/processes for labeling documentation management.
• A degree in scientific/life-sciences or related field, or equivalent experience. Significant experience in regulatory affairs with specific expertise in labeling.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

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