Associate Director, International Regulatory Affairs

Overview:

A global biopharmaceutical company on a mission to Solve On, Incyte follows science to find solutions for patients with unmet medical needs. Through the discovery, development, and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Hematology, Oncology and Inflammation and Autoimmunity

Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe, and Asia.

 

Job Summary (Primary function)

The Associate Director, International Regulatory Affairs works in collaboration with International Regulatory Affairs Lead to develop regulatory strategies with multi-functional teams and partners and ensures that International Regulatory Requirements for assigned products are complete. The Associate Director is also responsible for day-to-day coordination and preparation of regulatory submissions and will work and interact with internal cross-functional ream members in order to create regulatory submission documents that are compliant with International Regulatory Requirements. The Associate Director will collaborate with the International Regulatory Affairs Lead to liaise and co-lead meetings with International Health Authorities.

Essential Functions of the Job (Key responsibilities)

• Ensure close alignment and coordination with Global Multi-functional Team, International Business Unit, Alliance Management, Regional, and Country leads, fostering an inclusive environment that values diverse perspectives and collaboration. 
• Oversee and participate in preparation of dossiers containing technical, preclinical, and clinical data in a format suitable for use in obtaining regulatory approvals.
• Direct the activities of and interact with contract research organizations and/or distribution partners in the preparation of regulatory dossiers.
• Ensures accurate retention in the archival system of all regulatory submissions and contacts with health authorities. Ensures compliance with company`s policies and procedures and provides appropriate training to partners, as needed.
• Coordinate the preparation of responses to questions and inquiries from health authorities as well as ensure that regulatory maintenance submissions (e.g. Renewals and Annual Reports) are completed and submitted in accordance with regulatory submission schedules and requisite regulations.
• Communicate with health authorities as needed (e.g., phone calls, virtual meetings, in-person meetings).
• Ensure that data provided are presented clearly and succinctly to optimize the regulatory review and approval process.
• Responsible for coordinating the preparation and regulatory review of documents for regulatory submissions from all areas of the company.
• Works with Global Liaisons to agree contents, strategy and timelines for submissions to Health Authorities.
• Advises Incyte development teams of any unique scientific/regulatory requirements applicable in targeted regions.
• Review regulatory agency submission materials to ensure timeliness, accuracy, completeness, and compliance with regulatory standards.
• Manage the creation, review and submission of Orphan Designations, Priority Review Applications, GMP Certifications, HA Meeting Requests and Marketing Authorizations in the targeted regions. Evaluate regulatory requirements for regulatory approval and commercialization in targeted regions.
• Provide appropriate regulatory strategies to support submission of marketing and life-cycle applications (may also include support of clinical trial applications/expanded access programs) in International Markets Provides regulatory support to inter-departmental project teams.
• Research and understand regulations/guidance in International and assesses impact on regulatory strategies; communicates these impacts with recommendations to project teams.

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

• Strong knowledge of regulations/guidelines governing development of pharmaceuticals in International/Emerging markets.
• Strong collaboration and interpersonal skills and ability to develop and maintain strong connections with global, regional, and country leads as well as other key stakeholders. 
• Prior experience as a Regulatory Lead for a marketing application in a global market.
• Minimum of relevant experience in regulatory affairs, with a focus on International/Emerging markets, is preferred. (Typically 5 years experience in regulatory affairs 3 years or more focused on international emerging markets) 
• Bachelor's degree in a scientific discipline or equivalent experience, with advanced degree preferred.
• Willingness to travel up to 10% both domestic and international with reasonable accommodations provided to support candidates with disability

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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