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.
Manage the creation, review, and submission of regulatory documents (new protocols, new investigators, adverse events, periodic and annual reports, Development Safety Update Reports, nonclinical and clinical study reports, summary documents etc.) to support product development, clinical trials, and marketing applications in the US, EU, Canada, and rest of world as applicable.
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)
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.
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., Ph.D., Pharm.D.) is preferred. Degree in a scientific/life-sciences or related field a plus. Regulatory Affairs (RAC) Certification is a plus.
A minimum of 5 years direct responsibility for regulatory affairs with at least 8 or more years of drug development experience.
Strong working knowledge of the drug development process in the context of the scientific and commercial environment. Understanding of Canadian drug laws, regulations, guidelines, and policies, and their application to specific projects. Experience with Health Canada’s organizational structure and processes for the review and approval of drug submissions.
Proven record of successfully navigating complex regulatory environments and experience in developing and implementing regulatory strategies for novel products and technologies. Ability to think creatively, adaptively, and strategically about regulatory and reimbursement challenges.
Well-developed project management skills and ability to manage multiple strategic priorities and deliverables. Comfortable working with advanced document management systems, and desire to adopt innovative technologies to maximize capabilities and streamline the process of adapting global dossiers for Canadian submissions.
Fully bilingual, French, and English, in oral and written communications.
This role is to be located at Incyte Canada Headquarters in Montreal and will require up to 10% travel.
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.
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