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Regulatory Affairs Director

2 months ago

PointeClaire, Quebec, Canada Inctye Full time
Job Summary

The Director of Regulatory Affairs will play a critical role in ensuring the successful development and approval of our pharmaceutical products. This individual will be responsible for developing and implementing regulatory strategies to support our global development programs, ensuring compliance with regulatory requirements, and leading interactions with health authorities.

Key Responsibilities
  • Regulatory Strategy Development: Define and implement regulatory strategies to support successful global development programs.
  • Regulatory Document Management: Manage the creation, review, and submission of regulatory documents to support product development, clinical trials, and marketing applications.
  • Regulatory Agency Interactions: Liaise and lead team meetings with FDA and other health authorities to ensure timely regulatory approval and optimal labeling.
  • Regulatory Compliance: Ensure that all regulatory requirements are met, and compliance is maintained through effective working relationships with internal partners and external vendors.
  • Regulatory Guidance: Provide regulatory guidance to departments and/or development project teams regarding documentation and requirements for regulatory submissions.
Additional Responsibilities
  • Canadian Regulatory Function: Collaborate with global regulatory teams to facilitate regulatory activities, lead the preparation and compilation of regulatory submissions, and manage interactions with Health Canada.
  • Regulatory Affairs Strategy: Develop and implement regulatory affairs strategies to support business priorities, manage emerging issues, and provide regulatory review on messaging and promotional materials.
  • Regulatory Compliance: Ensure that all regulatory requirements are met, and compliance is maintained through effective working relationships with internal partners and external vendors.
Qualifications
  • Education: Bachelor's degree in a scientific/life-sciences or related field. Advanced degree (e.g., Ph.D., Pharm.D.) is preferred.
  • Experience: A minimum of 5 years direct responsibility for regulatory affairs with at least 8 or more years of drug development experience.
  • Skills: Strong working knowledge of the drug development process, understanding of Canadian drug laws, regulations, guidelines, and policies, and excellent communication and cross-functional negotiation skills.