at Incyte Corporation in Wilmington, Delaware, United States
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 International Regulatory Project Manager is responsible for planning, managing, and tracking the regulatory portfolio of international submissions for assigned programs. This role will be responsible for maintaining comprehensive plans, timelines, and submission deliverables for all major milestones and maintenance activities related to the filings, including the gap analysis process with local regulatory experts (partners) and submission content plans. This role will be responsible for facilitating timeline risk mitigation and contingency planning. This role will work with the regulatory team and key functions to maintain the latest dates, understand the change drivers, update the plan and keep stakeholders informed.
The International Regulatory Project Manager works in collaboration with multiple members of the regulatory and TechOps teams managing the submission planning (timelines), execution, and implementation throughout the product lifecycle in the international geographic region.
The International Regulatory Project Manager is also responsible for ensuring compliance with regulatory and quality systems by tracking and maintaining submission deliverables and milestones across the life cycle management of approved products. Management of the regulatory impact assessment of change controls with the cross-functional team, as well as providing reliable status reports to multiple stakeholders across the organization.
This role is critical for registration compliance to ensure new and continued patient access to Incyte pharmaceutical products.
Essential Functions of the Job (Key responsibilities)
Management of timelines for program milestones, submission deliverables, registration information, and health authority commitments.
Management of core dossier development and maintenance along with program strategy leads.
Management of the regulatory assessment of change controls with various functions within regulatory and the local regulatory experts (partners).
Collaborate with various regulatory functions (Reg Liaison, Reg CMC, Reg Ops, Reg Labeling) to ensure regulatory requirements are met in the targeted regions.
Discuss any particular regulatory strategies with the cross-functional team and partners to ensure successful submissions and approvals.
Evaluate submission risks, communicate mitigation plans and escalate (as appropriate).
Coordinate and track dispatch of core dossier/ core variation package to the international footprint.
Coordinate and track receipt of submission packages and health authority communications from partners.
Manage gap analysis process with local regulatory experts (partners) as well as Submission Content Plans.
Ensures compliance by tracking and managing all deliverables, information, metadata, and dates in the appropriate regulatory systems.
Ensure timely communications of regulatory milestones throughout the organization.
Generation of periodic reports and maintain appropriate trackers according to project needs.
Qualifications (Minimal acceptable level of education, work experience, and competency)
Minimum Bachelor`s degree in a scientific discipline, advanced degree preferred.
Minimum of 3 years' experience in regulatory affairs, international regulatory affairs preferred.
Two years' experience in qualified project or submission management (MS-Project, Share Point, generation of dashboards) is desirable.
Previous regulatory CMC experience is desirable.
Solid understanding of document management and regulatory information systems, Veeva RIM Vault is desirable.
Demonstrate time management/prioritization skills in a regulated environment.
Knowledge of the drug development process and experience of working with multiple regulatory agencies supporting regulatory dossier submission, review, and approval process throughout the product lifecycle.
Strong collaboration and interpersonal skills and ability to maintain reliable plans and reports.
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