Regulatory Manager (pharma)

Job Overview:

The Regulatory Manager leads the regulatory team and is responsible for overseeing, educating, and advising on medical, legal and regulatory (MLR) aspects of promotional material development.  This position will drive the development and implementation of regulatory processes, providing guidance to cross-functional teams and managing all aspects of the MLR review process. They will collaborate with creative, account management, and strategy teams to establish clear regulatory pathways, ensuring compliance while also facilitating timely approvals.

Key Responsibilities, including but not limited to:

• 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.

Requirements

Qualifications and Skills:

• Strong knowledge of FDA regulations and MLR processes.
• Demonstrated ability to lead teams and manage multiple projects simultaneously in a fast-paced environment.
• 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 Microsoft Office Suite.
• Previous experience in agency settings or working directly with pharma clients

Benefits

We are proud to offer a comprehensive benefits package to all of our employees:

• 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.
• And more! We offer flexible time off, life insurance, LTD, a robust employee assistance program, and more!

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.  

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