Director, Regulatory Affairs

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Regulatory Affairs based in Canada.

This is a senior regulatory leadership opportunity supporting the development of life-changing therapies from early clinical development through NDA/BLA <submission.You>’ll provide strategic and operational regulatory guidance to pharmaceutical, biotechnology, and clinical research clients.The role combines hands-on regulatory writing, scientific expertise, client leadership, and direct engagement with health <authorities.You>’ll serve as a trusted advisor to clients while leading complex regulatory development programs across clinical <phases.You>’ll collaborate with cross-functional scientific teams and act as a key point of contact with agencies such as the FDA.The position also offers opportunities to contribute to business development, marketing, and the continued growth of a global regulatory consulting practice.This is a fully remote role in a collaborative, international environment focused on accelerating therapies to patients.

Accountabilities

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.