Regulatory Affairs Coordinator, ATMF

Staff - Non Union

Job Category

M&P - AAPS

Job Profile

AAPS Salaried - Research and Facilitation, Level B

Job Title

Regulatory Affairs Coordinator, ATMF

Department

ATMF | Office of Research | Faculty of Medicine

Compensation Range

$7,158.42 - $10,292.25 CAD Monthly

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

September 27, 2026

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

Job End Date

December 31, 2028

 

 

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 Advanced Therapeutics Manufacturing Facility (ATMF) is a new Canada Foundation for Innovation (CFI)-funded initiative and a core component of Canada’s Immuno-Engineering and Biomanufacturing Hub (CIEBH)—a UBC-led national research hub that aligns immune-engineering expertise with biomanufacturing and public health strengths concentrated in British Columbia. This multi-year, multi-phase initiative aims to establish a Good Manufacturing Practice (GMP) biomanufacturing facility to produce advanced therapeutics—such as cell therapies, mRNA vaccines, and ancillary plasmid DNA—essential for early-phase clinical trials, addressing pressing health challenges, and strengthening Canada’s pandemic preparedness.

Reporting to the Director, GMP Operations, Quality Assurance and Regulatory Affairs, the Regulatory Affairs Coordinator independently manages assigned regulatory activities. The incumbent interprets regulatory requirements, evaluates regulatory impacts, coordinates deliverables, and provides expert guidance on submission and regulatory documentation requirements in accordance with Health Canada, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and International Council for Harmonisation (ICH) guidelines.

The role collaborates closely with Quality Assurance, Manufacturing, Quality Control, Process Development, Facilities, clinical collaborators, and academic and external partners to ensure regulatory standards are seamlessly integrated into ATMF's submissions, Chemistry, Manufacturing, and Controls (CMC) documentation, and product development activities.

This is a hands-on regulatory role in a highly regulated, fast-paced GMP environment that requires sound judgment, technical expertise, and the ability to work effectively across multidisciplinary teams.

Organizational Status
The University of British Columbia is a global centre for research and teaching, consistently ranked among the top public universities in the world. Since 1915, UBC’s entrepreneurial spirit has embraced innovation and challenged the status quo, encouraging students, staff, and faculty to lead discovery and explore new ways of learning.

Our Vision: To Transform Health for Everyone

Ranked among the world’s top medical schools with the fifth-largest MD enrollment in North America, the UBC Faculty of Medicine is a leader in both the science and practice of medicine. Across British Columbia, more than 12,000 faculty and staff train the next generation of healthcare professionals, make remarkable discoveries, and create pathways to better health globally. The Faculty comprises 19 academic basic science and clinical departments, 3 schools, and 25 research centres and institutes, delivering innovative programs alongside university and health authority partners.

The UBC Vancouver Campus is located on the traditional, ancestral, and unceded territory of the xʷməθkʷəy̓əm (Musqueam) people.

Within the ATMF GMP Operations team, the Regulatory Affairs Coordinator reports directly to the Director, GMP Operations, Quality Assurance and Regulatory Affairs. The incumbent coordinates, executes, and monitors regulatory activities, serving as the primary operational contact for ATMF’s regulatory submissions. Responsibilities include preparing pre-Clinical Trial Application (pre-CTA) briefing packages, Clinical Trial Applications (CTAs), Investigational New Drug (IND) application components, New Drug Submissions (NDS), amendments, and notifications.

Work Performed
1. Regulatory Strategy & Program Coordination

• Independently plans and manages assigned regulatory affairs activities across ATMF’s GMP manufacturing programs and advanced therapeutic development initiatives, determining applicable regulatory requirements, documentation and actions required to support compliance and submission readiness.
• Interprets and applies guidance from Health Canada, the FDA, the EMA, and the ICH to evaluate regulatory implications for manufacturing processes, facility readiness, equipment qualification, technology transfers, and product lifecycle decisions.
• Develops and implements regulatory plans for assigned programs based on applicable requirements, program risks and submission objectives, and establishes the timelines, commitments and monitoring mechanisms required for delivery.
• Independently assesses regulatory risks and their potential impact on ATMF programs and recommends mitigation strategies and required compliance actions to leadership and functional leads.
• Monitors regulatory intelligence and communicates regulatory updates that may impact ATMF operational programs.
• Evaluates ATMF operations against evolving regulatory expectations and recommends required changes to processes, documentation and controls to maintain regulatory compliance.

2. Regulatory Submissions & Documentation

• Leads assigned regulatory submissions by determining content and documentation requirements, evaluating materials for regulatory sufficiency, identifying deficiencies and ensuring the completed package meets applicable health-authority requirements before final approval.
• Assesses health-authority inquiries, determines the regulatory information required and develops recommended response strategies, lifecycle amendments and formal correspondence
• Independently evaluates CMC documentation for regulatory accuracy, consistency and sufficiency; identifies deficiencies and requires or recommends revisions before the package proceeds for approval.
• Collaborates with functional leads, who retain accountability for the validity of the underlying scientific and technical data.
• Ensures regulatory submission records and documentation are maintained in accordance with applicable regulatory, data-integrity and record-retention requirements.
• Monitors regulatory commitments and submission milestones, evaluates risks to delivery and determines or advises on corrective actions required to meet regulatory obligations.
• Utilizes regulatory information management systems and electronic submission tools (e.g., eCTD) to compile, publish, and track submissions.
  

3. Cross-Functional Regulatory Support & Operations

• Represents ATMF in assigned regulatory interactions, presents and explains regulatory information and advises leadership on the implications of health-authority feedback.
• Provides professional regulatory support to ATMF’s inspection-readiness program by evaluating submission histories and regulatory documentation for completeness and consistency, identifying potential risks and recommending corrective actions before audits and inspections.
• Supports ATMF's Quality Assurance-led inspection readiness program by compiling and organizing submission histories, correspondence, and CMC documentation for audits.
• Develops regulatory briefing materials and advises on key regulatory considerations and ensures resulting commitments are appropriately addressed.
• Establishes regulatory documentation standards and develops SOPs, templates and tools that translate health-authority requirements into consistent ATMF submission practices.

4. Regulatory Intelligence & Continuous Improvement

• Continuously monitors regulatory developments in advanced therapeutics and GMP manufacturing, translating regulatory shifts into actionable guidance for leadership.
• Evaluates regulatory processes and leads improvements within the assigned area to strengthen compliance, submission quality and regulatory readiness as ATMF scales its operations.

Consequence of Error/Judgement
The Regulatory Affairs Coordinator operates independently under general direction within established regulatory frameworks and organizational priorities. The incumbent applies professional judgment to interpret requirements, assess regulatory risks, and determine appropriate submission strategies.

Errors in judgment, inaccurate documentation, or non-compliance with regulatory timelines could result in delayed clinical trials, regulatory sanctions, formal rejections from health authorities, increased operational costs, or damage to the facility's and University's reputation. Complex or high-risk strategic decisions are escalated to the Director, GMP Operations, Quality Assurance and Regulatory Affairs. The incumbent routinely handles sensitive, proprietary product development data and must maintain strict confidentiality.

Supervision Received
Reports To: Director, GMP Operations, Quality Assurance and Regulatory Affairs

Supervision Given
Does not directly manage permanent staff, but may provide functional guidance and oversight to students, trainees, contractors, and project team members on regulatory deliverables.

Minimum Qualifications
Undergraduate degree in a relevant discipline. Minimum of three years of related experience, or the 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: Bachelor's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Biomedical Sciences, Engineering, or a related discipline.

·       Experience: Regulatory affairs experience in a biotechnology, pharmaceutical, biologics, advanced therapy, or relevant GMP-regulated environment. Relevant technical experience in biotechnology, pharmaceutical manufacturing, or translational research environments preferred.

Specialized Expertise

• Direct experience coordinating regulatory submissions or health authority interactions with Health Canada, the FDA, or the EMA.
• Experience supporting advanced therapy modalities (e.g., cell and gene therapies, viral vectors, RNA therapeutics, plasmid DNA, lipid nanoparticle [LNP] platforms).
• In-depth familiarity with ICH guidelines, FDA CBER requirements, Health Canada Biologics and Radiopharmaceutical Drugs Directorate (BRDD) guidance, EU GMP, and structural CMC documentation.

Knowledge & Skills:

• Demonstrated experience interpreting regulatory requirements and preparing formal regulatory submissions.
• Working knowledge of GMP principles as applied to biological products.
• Strong technical writing, professional communication, and project management skills.
• Proven ability to coordinate complex priorities across cross-functional teams.