Canopy Life Sciences · 3 days ago

Regulatory Affairs Advertising and Promotional Reviewers

Danbury, CT

Full-time

Remote

Director/Executive

5+ years exp

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Responsibilities

Act as the primary Regulatory expert within an assigned client’s Medical, Legal, and Regulatory (MLR) team, providing balanced strategic counsel and tactical support on both commercial and development programs.

Conduct solutions-oriented and collaborative review and approval of all advertising and promotional materials, disease-awareness, scientific publications, training, and medical education materials and programs throughout an assigned product’s lifecycle.

Maintain up-to-date knowledge of FDA laws, regulations and guidance documents, as well as the compliance environment as it relates to the advertising and promotion of pharmaceutical products and medical devices and advise teams as appropriate.

Support the review of proposed updates to package inserts/labeling, offering input on potential promotional messages and claims. Collaborate with teams to help integrate relevant labeling changes into product promotional materials as needed.

Support a variety of Regulatory Affairs initiatives within the Canopy Life Sciences Regulatory Affairs department related to ongoing process improvement, as assigned.

Qualification

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Pharmaceutical Regulatory ReviewAdvertising Regulatory CompliancePromotional Material ReviewFDA Regulations KnowledgeCross-Functional Collaboration

Required

At least 5 years of pharmaceutical/medical device advertising and promotional regulatory review.

Ability to work independently in a remote role with minimal oversight.

Proven ability to manage multiple priorities simultaneously, maintaining focus and meeting deadlines in a fast-paced environment while balancing diverse tasks and responsibilities.

Strong team-oriented mindset with a collaborative attitude, able to work effectively with internal and external cross-functional teams to achieve common goals and drive successful outcomes.

Bachelor’s degree