Regulatory Affairs Director

5 days ago


PointeClaire, Quebec, Canada Incyte Corporation Full time
Job Summary

The Director of Regulatory Affairs will play a pivotal role in ensuring the successful development and approval of Incyte's novel medicines. This individual will work closely with cross-functional teams to develop and implement regulatory strategies, ensuring compliance with global regulatory requirements.

Key Responsibilities
  • Develop and execute regulatory strategies to support global product development programs.
  • Manage the creation, review, and submission of regulatory documents to support product development, clinical trials, and marketing applications.
  • Review and ensure compliance with regulatory agency submission materials, including IND, CTA, NDA, MAA, and other regulatory submissions.
  • Collaborate with internal partners to ensure alignment of regulatory affairs strategy with business priorities.
  • Liaise with Health Canada and other regulatory authorities to ensure timely regulatory approval and optimal labeling.
  • Manage and oversee external vendors responsible for locally outsourced regulatory activities.
  • Develop effective working relationships with opinion leaders and stakeholders.
  • Monitor the regulatory environment and interpret changes to ensure compliance and regulatory strategy alignment.
Requirements
  • Bachelor's degree in a scientific or life sciences field, with advanced degree preferred.
  • Minimum 5 years of direct responsibility for regulatory affairs, with at least 8 years of drug development experience.
  • Strong working knowledge of Canadian drug laws, regulations, guidelines, and policies.
  • Proven record of successfully navigating complex regulatory environments and developing regulatory strategies for novel products.
  • Leadership experience in managing global cross-functional teams and excellent communication and negotiation skills.
  • Well-developed project management skills and ability to manage multiple strategic priorities and deliverables.
  • Fully bilingual, French and English, in oral and written communications.
Additional Information

This role is located at Incyte Canada Headquarters in Montreal and requires up to 10% travel. The successful candidate will be responsible for ensuring compliance with all regulatory requirements and developing effective regulatory strategies to support Incyte's business objectives.



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