Director, Regulatory Affairs, Canada

Overview:
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 Director, Regulatory Affairs, will work with multi-functional teams to develop the regulatory strategy and ensure that regulatory requirements for assigned products are complete. The position will liaise and lead team meetings with FDA and other Health Authorities.

Essential Functions of the Job (Key responsibilities)
- Defines appropriate regulatory strategies to support successful global development programs.
- Review regulatory agency submission materials to ensure timeliness, accuracy, completeness, and compliance with regulatory standards.
- Ability to read and understand all components of a regulatory submission (IND, CTA, NDA, MAA, etc.) to ensure consistency across documents.
- Ensure that dossiers containing technical, nonclinical, and clinical data are presented clearly and succinctly to optimize the regulatory review and approval process.
- Ensure regulatory guidance documents and laws, as well as internal policies and procedures, are followed to ensure regulatory compliance is maintained.
- Coordinate the preparation of responses to questions and inquiries from health authorities.
- Liaise with FDA and other health authorities as needed (e.g. telephone contacts, teleconferences, meetings, submissions).
- Ensures accurate retention in the archival system of all regulatory submissions and contacts with health authorities.
- Maintain current knowledge of relevant US and international guidance’s, laws and regulations, and proposed and final rules which affect pharmaceutical drug development and companion diagnostics.
- Provide regulatory guidance to departments and/or development project teams regarding the documentation and requirements for regulatory submissions.
- Keep employees informed of relevant regulatory guidance documents, regulations and information.
- Excellent communication skills; both oral and written.
- Excellent interpersonal skills with the ability to influence others in a positive and effective manner and work across boundaries to establish common purpose and goals.
- Demonstrated ability to champion a continuous learning and process improvement environment.
- Excellent analytical and organizational skills and ability to support multiple projects in a timeline-driven environment.
- Experience with document management systems, eCTD submissions managing, and maintaining regulatory files preferred.

Additional Responsibilities (specific to Canadian Regulatory Function)
- Collaborate with global regulatory teams and the Global Regulatory Affairs (GRA) function/teams to facilitate regulatory activities.
- Lead the preparation and compilation of regulatory submissions including New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), Notifiable Changes (NCs), and ad hoc reports to Health Canada and maintain the life cycle of currently marketed products.
- Manage in coordination with Global Regulatory and Development teams the preparation and review of responses to Health Canada queries in a timely manner.
- Lead interactions with Health Canada throughout the submission review cycle to ensure timely regulatory approval, optimal labeling, and implementation of local regulatory strategies.
- Collaborate with internal partners to ensure alignment of regulatory affairs strategy with business priorities.
- Manage and oversee external vendors responsible for locally outsourced regulatory activities, including Incyte’s Drug Establishment License.
- Develop effective working relationships with opinion leaders as needed.
- Manage emerging issues (e.g., new safety or quality finding) and associated risk communications to stakeholders.
- Provide regulatory review on messaging, promotional material review, PAAB responses, and external regulatory communications (“Dear Doctor Letters,” etc.).
- In collaboration with QA and Global Pharmacovigilance, support activities related to internal and external (Health Canada and other regulatory authorities) audits for Clinical Studies, Pharmacovigilance, and regulatory compliance.
- Monitor the regulatory environment, interpret changes, analyze gaps, and conduct impact assessments.
- Help shape Health Canada policies to pave a favorable regulatory environment for pipeline products through participation in pharmaceutical association meetings.

Qualifications (Minimal acceptable level of education, work experience, and competency)
- Bachelor’s degree. Advanced degree (e.g.