Regulatory Affairs Director jobs in Delaware

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

The Associate Director, Global Regulatory Affairs Labeling, will be responsible for regulatory support in the area of product labeling. This position reports to the Director, Global Regulatory Affairs Labeling and will be responsible for creating, updating, and maintaining labeling documents throughout the product lifecycle, with primary focus on Company Core Data Sheets and regional/local labels for products marketed globally. This position will help maintain records for labeling changes and communicate labeling changes to stakeholders. As needed, this position will also support the implementation of process improvement changes to increase the efficiency and effectiveness of labeling processes. This role may collaborate with external partners.

Key responsibilities

* Leads cross-functional teams in the development, revision, review, and approval of Company Core Data Sheet and regional/local product labeling documents, for assigned products, in line with regulatory and internal standards and guidelines.

* Provides labeling expertise and guidance to teams about labeling content, processes, and timelines.

* In collaboration with Supply Chain, contributes to the development of new and updated packaging mock-ups and artwork for submission purposes.

* Serves as the point of contact on Global Regulatory Affairs sub-teams to ensure delivery of labeling documents that meet quality, compliance, and regulatory labeling standards, to support timely regulatory submissions for assigned products.

* Ensures high quality and compliant labeling documents.

* Contributes to the continuous improvement of the end-to-end labeling process.

* Supports internal and external audits/inspections as a labeling subject matter expert.

Qualifications

* Bachelor's degree in a scientific discipline. Advanced degree preferred (MS, PharmD, PhD).

* Relevant experience in the pharmaceutical industry including 4 years of direct regulatory labeling experience.

* US labeling experience required; ex-US labeling experience preferred.

* Ability to guide cross-functional teams (including senior management) and drive consensus to address labeling issues.

* Self-starter with an ability to assimilate clinical and scientific information and present it concisely. Understanding of medical concepts and terminology.

* Strong project management skills with the ability to handle multiple projects and prioritize work accordingly.

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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