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CG Life · 1 day ago

Regulatory Manager (Pharma)

United States

Full-time

Remote

Mid, Senior Level

$95K/yr - $110K/yr

3+ years exp

CG Life is a company focused on regulatory excellence in the pharmaceutical sector. The Regulatory Manager is responsible for overseeing client accounts, ensuring compliance with FDA regulations, and leading high-complexity regulatory submissions while mentoring a team of specialists.

Marketing & Advertising

Culture & Values

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

Qualification

Regulatory strategyFDA regulationsMLR processesProject management toolsAdobe AcrobatMicrosoft Office SuiteSupervisory experienceChange managementHealthcare industry experienceVeeva Vault PromoMatsCommunicationDetail-orientedTeam leadership

Required

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

Preferred

Previous experience in agency settings or working directly with healthcare clients

Working knowledge of Veeva Vault PromoMats or similar content management and review platform

Benefits

Medical, Dental & Vision Insurance. We cover a generous portion of employee contributions

401K plan. We invest in present and future you, which is why we offer a generous match and immediate vesting on our plan

Parental Leave. Generous paid time off for parents to bond with their newest addition

Professional Development. Each employee has an annual budget to allocate to professional development opportunities. Employees are encouraged to take a workshop, attend a webinar, join associations, and do anything else that will help them grow in their careers.

Flexible time off

Life insurance

LTD

A robust employee assistance program