Regulatory Affairs Manager/Specialist

Toronto, ON or Remote

Job Summary

Our client is seeking a Regulatory Affairs Manager or Specialist with strong medical writing capabilities to support regulatory initiatives across North America. The successful candidate will contribute to regulatory strategy, oversee submission activities, and ensure adherence to regional and international requirements for both new and marketed therapies. This is a high-impact role requiring technical regulatory expertise and the ability to produce high-quality scientific documentation.

Key Responsibilities

• Support the development and execution of regulatory strategies to enable product approvals and maintain compliance throughout the product lifecycle.
• Prepare, review, and manage submissions such as INDs, CTAs, NDAs, ANDAs, BLAs, MAAs, and other international filings.
• Serve as a primary author of key regulatory and clinical documents.
• Interpret and apply regulatory guidelines and requirements to ensure submission accuracy and compliance.
• Work collaboratively with internal stakeholders across clinical development, pharmacovigilance, medical affairs, research, and manufacturing to compile necessary data.
• Offer regulatory insights and direction across all development phases.
• Keep current with evolving regulatory frameworks and industry best practices.
• Represent the organization in regulatory interactions with agencies such as the FDA, Health Canada, and other global authorities.
• Identify potential regulatory risks and contribute to mitigation planning.
• Provide mentorship and knowledge sharing to less experienced team members when needed.

Qualifications

• Bachelor's degree in life sciences, pharmacy, or related discipline; advanced degree is an asset.
• 3-5+ years of regulatory affairs experience within the pharmaceutical, biotech, or related health sciences sector.
• Demonstrated experience in medical writing.
• Proven success in preparing and submitting regulatory dossiers.
• Deep understanding of regulatory frameworks (e.g., FDA, Health Canada, EMA, ICH).
• Strong written and verbal communication skills, with the ability to translate complex scientific concepts into clear, concise documents.
• Highly organized, with strong project management and attention-to-detail.
• Able to thrive in both independent and team-oriented environments.

Thank you in advance for your interest, only individuals deemed to have the skill set and experience to fit the role will be contacted. Applicants must be legally entitled to work in Canada without sponsorship.

Lock Search Group is a National Executive Recruitment firm with 11 offices in Canada and one in the United States, a staff of more than 30 Consultants and Associates, and expertise in 11 major disciplines. Our mission is to provide exceptional Recruitment and Consulting Services to clients and candidates. We apply our experience and expertise to deliver solutions with a personalized approach that focuses on client needs and candidate goals.

Follow us on LinkedIn !