Regulatory Affairs Manager

Title: Regulatory Affairs (AdPromo)

Location: Canada

Duration: 3 years

CAP 20 hours per week

Company Overview

Apsida Life Science is partnering with an organisation dedicated to community-based clinical trials, ensuring excellent participant care and a smooth transition from hospital to home in accordance with study protocols, clinical practice regulations, and ICH-GCP requirements.

Responsibilities:

• Review Canadian promotional, educational, medical and corporate communications, as applicable, for alignment with relevant regulatory requirements, approved product information and industry standards.
• Apply knowledge of Health Canada advertising requirements, the Canadian Product Monograph and applicable PAAB standards in the assessment of materials.
• Provide regulatory input on the overall content, messaging and presentation of materials, identifying compliance considerations and recommending practical solutions.
• Represent Canadian Regulatory Affairs in Promotional Material Review Team (PMRT) and Medical Review Committee (MRC) discussions, as applicable.
• Collaborate with Marketing, Medical, Legal and other partners to facilitate efficient review and approval of materials through established internal processes.
• Support the Canadian adaptation of global materials and guide questions related to promotional versus non-promotional communications.
• Maintain alignment with Canadian Regulatory leadership and the broader Regulatory Ad Promo team and escalate significant regulatory concerns as appropriate.

Qualifications:

• University degree in a scientific or health sciences discipline (e.g., Life Sciences, Pharmacy, Biology, or Chemistry) or a related field. Additional education or certification in Regulatory Affairs is considered an asset.
• At least five years of relevant experience in pharmaceutical or biotechnology Regulatory Affairs, including at least two years of advertising and promotional review experience.
• Working knowledge of Canadian pharmaceutical advertising requirements, Health Canada guidance and the PAAB Code, with experience participating in cross-functional material review.
• Strong regulatory judgment, communication and collaboration skills, with the ability to work independently, manage priorities and provide clear, solutions-oriented recommendations.

If you are interested in learning more or wish to apply, please reach out to Sweetness Zono at Apsida Life Science: Email: [email protected] Website: www.apsida.co.uk

Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa), dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective, high-quality, and trusted recruitment service that puts the candidate journey at the heart of the recruitment process