Apply on Employer Site

CG Life · 1 month ago

Regulatory Manager (pharma)

United States

Full-time

Remote

Senior Level

CG Life is a company that specializes in the pharmaceutical industry, and they are seeking a Regulatory Manager to lead their regulatory team. This role involves overseeing the development and implementation of regulatory processes, ensuring compliance with FDA regulations, and providing guidance to cross-functional teams on promotional material development.

Marketing & Advertising

Culture & Values

Responsibilities

Lead the regulatory strategy and execution for promotional content, ensuring adherence to FDA regulations and internal guidelines

Act as the primary point of contact for MLR reviews, providing regulatory expertise and guidance to internal teams and clients

Develop and maintain regulatory policies, procedures, and training materials to ensure compliance across all teams

Conduct thorough reviews of promotional materials to ensure accuracy and compliance with relevant regulations

Track industry trends and changes in regulatory requirements, proactively updating internal processes and training as necessary

Mentor and develop the regulatory team to enhance their understanding of compliance challenges and best practices

Collaborate with clients to address regulatory questions and concerns, fostering positive relationships and ensuring satisfaction

Participate in senior leadership meetings to report on regulatory compliance status and present improvements

Work to increase the efficiency of the MLR review process through streamlined workflows and enhanced communication

Qualification

Regulatory strategyFDA regulationsRegulatory compliancePolicy developmentTeam leadershipIndustry trend analysisCross-functional collaborationMentoring