Job Title: Regulatory Affairs Manager (Part-Time, Canada-Based)
Location: Toronto, ON, Canada (Remote)
Company: Advanced Clinical
Company Overview: Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience throughout the drug development journey. Our mission is to improve the lives of those touched by clinical research, driven by foresight, character, resilience, and innovation. Through decades of experience, we help clients achieve better outcomes with customized solutions, proactive communication, and strategic problem-solving.
Position Overview: The Regulatory Affairs Manager (RA) will be responsible for partnering cross-functionally to develop and implement global regulatory strategies. This includes driving pipeline development, lifecycle management, ensuring compliance, and meeting clinical trial and regulatory performance deliverables for contracted clinical programs. The RA Manager will also play a key role in business development, policy creation, and cross-departmental collaboration.
This is a part-time position that will be based in Canada.
Key Responsibilities:
Regulatory Strategy & Compliance:
Serve as the regulatory primary point of contact for assigned projects and regulatory agencies.
Develop and implement global regulatory strategies for new product development, lifecycle management, and international registrations.
Ensure compliance with regulations and standard operating procedures (SOPs).
Prepare, submit, and maintain regulatory documents for clinical trial and product registration (eCTD, IND, NDA, BLA, MAA, amendments, variations, renewals).
Monitor global regulatory trends and assess their impact on organizational processes.
Project Management & Collaboration:
Collaborate cross-functionally with project teams to meet submission deadlines and regulatory requirements.
Act as a regulatory representative for working groups conducting gap analyses and business impact assessments of new and changing regulations.
Provide technical regulatory improvements and guidance to optimize strategies across functional areas.
Manage resource allocation and balance critical projects.
SOP Development & Audits:
Review and provide feedback on SOPs related to regulatory, clinical, and pharmacovigilance activities.
Support regulatory compliance during audits and inspections.
Educate colleagues on regulatory policies and best practices.
Training & Development:
Establish and implement learning initiatives for cross-functional partners on current and emerging regulatory requirements.
Mentor and support the development of junior staff.
Business Development:
Provide strategic input into business development proposals.
Contribute to the development, enhancement, and expansion of regulatory services to support client growth.
Qualifications:
Bachelor of Science degree in Life Sciences, Chemistry, Pharmacy, or equivalent work experience (MS/MSc or PhD preferred but not required).
Minimum 5+ years of relevant regulated industry experience (MedTech, Pharma, CRO).
Experience communicating with regulatory/health authorities, including FDA and Health Canada.
Strong knowledge of the eCTD format, global clinical trial requirements, and applicable regulatory frameworks.
Product licensing (NDA/BLA/MAA) and post-marketing experience preferred.
Proficiency in MS Office and Regulatory Information Management Systems.
Excellent verbal, written, and presentation communication skills.
Strong organizational, analytical, and problem-solving capabilities.
Ability to manage multiple projects and work independently in a fast-paced environment.
Commitment to fostering an inclusive and diverse work environment.
Why Join Advanced Clinical?
Be part of a mission-driven organization that values innovation, character, and collaboration.
Work with a diverse team dedicated to providing a better clinical experience.
Enjoy flexibility with a part-time, remote role based in Canada.
How to Apply: If you are passionate about regulatory affairs and want to contribute to impactful clinical development programs, we invite you to apply for this exciting opportunity.
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