SHAWNEE is seeking a highly skilled and detail-oriented Contract Manager of Regulatory Affairs Advertising to lead our clients regulatory compliance initiatives related to promotional activities within the pharmaceutical and biomedical sectors. The successful candidate will oversee regulatory submissions, manage compliance projects, and collaborate with cross-functional teams to uphold the highest standards of regulatory integrity. Represent regulatory on global and certain regional PRC (Promotional Review Committee) teams, SRC (Scientific Review Committee) teams and possess a thorough knowledge of regulations for advertisement and promotional compliance governing device products (drug product experience acceptable) and the ability to translate regulatory requirements into decision-ready guidance for stakeholders. Develop, review, and approve advertising and promotional materials in compliance with FDA regulations, EMA guidelines, and other relevant regulation policies. Maintain comprehensive documentation of all regulatory activities related to advertising compliance.
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