Regulatory Affairs Lead

Staff - Non Union

Job Category

M&P - AAPS

Job Profile

AAPS Salaried - Research and Facilitation, Level C

Job Title

Regulatory Affairs Lead

Department

Regier Laboratory | School of Population and Public Health | Faculty of Medicine

Compensation Range

The Compensation Range is the span between the minimum and maximum base salary for a position. The midpoint of the range is approximately halfway between the minimum and the maximum and represents an employee that possesses full job knowledge, qualifications and experience for the position. In the normal course, employees will be hired, transferred or promoted between the minimum and midpoint of the salary range for a job.

Posting End Date

November 14, 2025

Note: Applications will be accepted until 11:59 PM on the Posting End Date.

Job End Date

November 30, 2026

At UBC, we believe that attracting and sustaining a diverse workforce is key to the successful pursuit of excellence in research, innovation, and learning for all faculty, staff and students. Our commitment to employment equity helps achieve inclusion and fairness, brings rich diversity to UBC as a workplace, and creates the necessary conditions for a rewarding career.

Job Summary

The Regulatory Affairs Lead will be a key member of Dr. Dean Regier's Regulatory Science Lab research team. We are seeking an exceptional candidate with expertise in Regulatory Affairs and a strong background in regulatory and quality compliance, submissions, planning, and strategy. The successful candidate will have experience and interest in cultivating strong relationships across the life sciences sector, including small and medium biopharma and medtech companies, national and international regulatory bodies, partner institutions, health authorities, industry consortia, collaborative research partners, and other stakeholders. They will lead planning, management, coordination, and communication of regulatory affairs research, projects, and strategies for the Academy of Translational Medicine (ATM).

Organizational Status

Housed within the Faculty of Medicine, the School of Population and Public Health (SPPH) is an innovative unit that encompasses many of the health-related groupings at UBC as a collaborative venture. The School is structured around four divisions: Occupational and Environmental Health; Health Services and Policy; Epidemiology, Biostatistics and Public Health Practice; and Health in Populations. The resulting mix of professions and disciplines is seen as a means of connecting individuals and learners to galvanize the relationship between health research, public health and health services and to enhance learning.

The ATM at the University of British Columbia (UBC) is established by the Faculty of Medicine. The ATM is a nucleus for translational and regulatory science research, education and training, and innovation. The ATM is a strategic imperative for the Faculty of Medicine and has a mandate to collaborate with other units in the Faculty of Medicine, the wider University, and beyond to accelerate the translational medicine continuum. The ATM will drive impactful medical and policy research to create new knowledge to improve health outcomes and benefit society. The ATM is the nucleus for the development of new academic and training programs, creating a cutting-edge ecosystem in which top educators and researchers train the next generation of health innovators.

Work Performed

• Responsible for the planning, development, design, management implementation and communication of regulatory strategies and projects for the ATM, in collaboration with provincial, national, and international cross-sector research and innovation partners.
• Develops regulatory infrastructure and works to establish regulatory science practices and policies, including continuously monitoring and reviewing regulations, policies, and practice requirements related to translational medicine and regulatory science, identifying gaps and opportunities for improvement.
• Provides expertise in the field of Regulatory Sciences and Affairs
• Develop and define use cases and functional requirements for regulatory support tools, including commercialization pathways, summarizing regulatory guidelines, providing compliance recommendations, advising on documentation, and responding to regulatory queries.
• Engage key stakeholders—including UBC scientists/departments, UBC Innovation, BC innovators, regulatory and commercialization experts, healthcare professionals, and legal advisors—to establish the essential functions, boundaries, and compliance considerations for emerging use of AI tools in regulatory affairs.
• Consults with and advises stakeholders from local BC companies and UBC scientists as well as from the Canadian bio-innovation sector developing new health products, providing end-to-end regulatory and translational support.
• Serve as a key point of contact to facilitate communication, alignment, and collaboration with national regulatory and reimbursement agencies throughout the product life cycle or policy engagement process, including Health Canada, l'Institut national d'excellence en santé et en services sociaux (INESSS), and Canada's Drug Agency (CDA–AMC).
• Leads the redesign, development, execution and implementation of the ATM's Regulatory Science educational programs.

Consequence of Error/Judgement

The incumbent is given wide latitude for exercising independent initiative and judgment in performing specialized duties and responsibilities. A lack of judgment could harm the research team and partner organizations' research and funding. The incumbent will interact with multiple researchers across various organizations to address their data needs and research findings, and discretion is vital.

This position will be responsible for access, collection, use and disclosure of personal information in accordance with the BC Freedom of Information and Protection of Privacy Act (RSBC 1996) and other UBC privacy and security policies. This position requires employees to work under strict confidentiality requirements; internal procedures and policies to protect personal information must be followed and adherence to these requirements will be regularly reviewed by the employer.

Supervision Received

The incumbent will be able to work independently with minimal supervision and regularly report to the Regulatory Science Lab Principal Investigator. The incumbent will also receive support from research collaborators as needed. Performance will be reviewed periodically based on the quality and timeliness of work.

Supervision Given

The incumbent may assist the Regulatory Science Lab Principal Investigator with the supervision and mentoring of junior research trainees, and may also provide technical guidance to research staff and trainees.

Minimum Qualifications

For research work, a post-graduate degree or equivalent professional designation with a minimum of four years of related experience, or an equivalent combination of education and experience. Otherwise, an undergraduate degree in a relevant discipline is required with a minimum of six years of related experience, or an equivalent combination of education and experience.

• Willingness to respect diverse perspectives, including perspectives in conflict with one's own

• Demonstrates a commitment to enhancing one's own awareness, knowledge, and skills related to equity, diversity, and inclusion

Preferred Qualifications

• Education in regulatory science, regulatory affairs, or business administration and/or biomedical research. PhD in a relevant discipline preferred.
• 10+ years of progressive experience in regulatory affairs is preferred.
• Demonstrated leadership in managing regulatory teams and projects in a Canadian or global environment.
• Proven track record of successful grant development and submissions.
• In-depth knowledge of national and global regulatory standards
• Experience preparing regulatory submissions (510(k), CE, Health Canada, WHO, etc.), overseeing product licensing, complaint handling, post-market surveillance, labeling, and change notifications.
• Experience partnering with R&D, Quality, and Operations teams to ensure market readiness
• Monitor and interpret evolving regulatory requirements, updating policies and processes as needed
• Experience working at a management level within an academic setting with related experience in strategy development and implementation of academic and research programs.
• Experience in a senior administrative role managing complex relationships, preferably in a university environment or other large organization.
• Knowledge and experience in organizational governance.
• Demonstrated experience in financial, human resources and communications management.
• Experience in the development and review of research proposals and development of program reports.