Director, Regulatory Affairs

• Provide strategic regulatory advice to clients throughout the product development lifecycle, with particular focus on early development through NDA/BLA submissions.


• Independently prepare and oversee regulatory documentation, including US IND submissions, NDA/BLA modules, Orphan Drug Designation applications, Fast Track and other regulatory designations, and FDA advice requests.


• Lead regulatory development projects and provide scientific and regulatory guidance across cross-functional teams.


• Serve as a client-facing regulatory advisor and primary point of contact for regulatory matters, building strong relationships and maintaining clear communication throughout projects.


• Lead interactions with health authorities, including the FDA, and support preparation for regulatory meetings, submissions, and agency communications.


• Collaborate with internal scientific, clinical, and operational teams to ensure regulatory strategies align with broader development objectives.


• Contribute to business development and marketing activities by supporting client opportunities, developing regulatory perspectives, and representing regulatory expertise externally.


• Provide technical and supervisory leadership to team members, setting high standards for regulatory quality, collaboration, and client service.

Requirements

• Bachelor’s degree in science, toxicology, pharmacology, engineering, or a related scientific discipline; a Master’s degree, Ph.D., or Pharm.D. with relevant clinical-trial training is preferred.


• 10+ years of relevant experience within a CRO or pharmaceutical company, including at least 5 years leading regulatory development projects.


• Thorough knowledge of ICH Good Clinical Practice (GCP) guidelines and applicable international regulatory requirements and guidance.


• Strong understanding of medical terminology, clinical trials, clinical research, and regulatory requirements across Phase I–IV studies.


• In-depth understanding of the CRO industry and the regulatory responsibilities and relationships between CROs and pharmaceutical or biotechnology organizations.


• Demonstrated experience developing regulatory strategies and documentation for submissions and interactions with health authorities.


• Excellent technical, scientific, and regulatory writing skills, combined with strong verbal communication and presentation abilities.


• Demonstrated technical and supervisory leadership skills, with the ability to lead by example and develop team members.


• Strong interpersonal, organizational, and problem-solving skills, with the ability to manage priorities independently while collaborating effectively in a team environment.


• Proficiency with Microsoft Word, Microsoft Excel, and other relevant software, along with the ability to quickly learn new applications.

Benefits

• Estimated US hiring range of $195,000–$223,000, plus applicable bonus; compensation for Canada and other regions is adjusted according to local market conditions.


• Final compensation determined based on factors including skills, experience, education, certifications, licensure, location, and market data.


• Fully remote working environment.


• Flexible time off.


• Paid holidays.


• Medical insurance, subject to location and eligibility.


• Tuition reimbursement, subject to location and eligibility.


• Retirement plans, subject to location and eligibility.


• Opportunity to work with an international team supporting the development of therapies that can improve and save lives.


• Inclusive and flexible workplace culture with a strong emphasis on diversity and collaboration.