Regulatory Manager (Pharma)

Job Overview:

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.

Key Responsibilities, including but not limited to:

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.

 

Qualifications and Skills:

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

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

Reports To: Associate Director, Regulatory

At CG Life, we recognize that attracting the best talent is key to our strategy and success as a company. As a result, we aim for flexibility in structuring competitive compensation offers to ensure we are able to attract the best candidates. As required by law in this state, the estimated salary range for this position is $95,000- $110,000 USD and represents our good faith estimate as to what our ideal candidates are likely to expect. We tailor our offers within the range based on organizational needs, internal equity, market data, geographic zone, and the selected candidate’s experience, education, industry knowledge, location, technical and communication skills, and other factors that may prove relevant during the selection process. At CG Life, it is not common for individuals to be hired at the higher end of the range, and compensation decisions depend on a variety of factors. This position is eligible to participate in a discretionary bonus program, subject to the rules governing the plan. CG Life offers a variety of benefits, including health benefits, 401K retirement with a generous company match and immediate vesting, and flexible time off.  

A Note to Candidates:

It has come to our attention that some candidates are being contacted by individuals falsely claiming to represent CG Life. Please note that all official communications from CG Life will come from an email address ending in @cglife.com . If you are contacted by anyone using a different domain, please consider it fraudulent. CG Life will never ask candidates to pay fees or share financial information at any stage of the hiring process

This job posting is intended for direct applicants only; please, no outside recruiters.