Regulatory Affairs Manager
Apsida Life Science
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 elevate 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.
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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 elevate 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.
#J-18808-Ljbffr
Vacancy posted 50 minutes ago
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