Regulatory Manager (Pharma)

CG Life

1d•$95,000 - $110,000

About The Position

The Regulatory Manager is a regulatory leader responsible for overseeing assigned client account(s) from a regulatory perspective. This role serves as a strategic partner to internal and client teams, ensuring regulatory excellence across all projects within the assigned account, and is responsible for executing the highest-complexity, highest-visibility projects on that account while maintaining compliance with applicable medical, legal, and regulatory (MLR) requirements. The Regulatory Manager also plays a critical management role, supervising and developing Regulatory Specialists and Senior Regulatory Specialists.

Requirements

Bachelor's degree (Life sciences, healthcare, communications, English, or similar) or equivalent experience (recommended)
3+ years experience with regulatory or legal review processes in healthcare or other regulated industry, or 2+ years agency experience in regulatory or editor role, or equivalent experience in a client-side MLR-focused role
2+ years supervisory experience or equivalent education/training
Strong knowledge of FDA regulations and MLR processes.
Demonstrated ability to lead teams and manage multiple projects simultaneously in a fast-paced environment.
Successful history of guiding change
Excellent written and verbal communication skills, with a keen eye for detail.
Proficient in the use of project management and collaboration tools, as well as Adobe Acrobat and Microsoft Office Suite.

Nice To Haves

Previous experience in agency settings or working directly with healthcare clients
Working knowledge of Veeva Vault PromoMats or similar content management and review platform

Responsibilities

Lead the regulatory strategy and execution of the highest-complexity, highest-priority, and most visible regulatory submissions, 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 for assigned account(s) 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, working with the Associate Director and Director of Regulatory to improve internal processes and training as necessary.
Mentor and develop direct reports to enhance their understanding of compliance challenges and best practices, and oversee their workload distribution, performance management, and professional development.
Collaborate with clients to address regulatory questions and concerns, fostering positive relationships and ensuring satisfaction.
Participate in 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.