Manager Regulatory Affairs Advertising

Job Summary

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. This pivotal role involves ensuring that all advertising and promotional materials adhere strictly to applicable regulations, including FDA, EMA, and other international health authorities. The successful candidate will oversee regulatory submissions, manage compliance projects, and collaborate with cross-functional teams to uphold the highest standards of regulatory integrity. This position offers an opportunity to influence global regulatory strategies and ensure our communications meet rigorous legal and ethical standards.

Duties

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.

MUST have the education and experience to be able to review and conduct analysis independently in order to assist with the team's workload.

Bachelors degree minimum. 5 years or more DIRECT experience reviewing Advertising and Promotional pieces for the US market. It is NOT acceptable to only have experience in Regulatory Affairs in general.

Develop, review, and approve advertising and promotional materials in compliance with FDA regulations, EMA guidelines, and other relevant regulation policies.
Manage regulatory submissions related to advertising campaigns, including preparing documentation for FDA submissions and other international authorities.
Oversee compliance management processes to ensure all promotional activities align with pharmaceutical regulatory requirements.
Lead regulatory compliance projects focused on biomedical regulatory compliance and drug regulation standards across multiple jurisdictions.
Monitor evolving health regulation policies globally to adapt advertising strategies accordingly.
Coordinate internal audits and support external inspections related to advertising practices.
Provide expert guidance on FDA regulations, ISO standards specific to the location, and other applicable quality assurance protocols.
Facilitate training sessions for staff on regulatory requirements pertaining to advertising and promotional activities.
Maintain comprehensive documentation of all regulatory activities related to advertising compliance.

Pay: $90.00 - $100.00 per hour

Work Location: In person