Description
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.
Similar jobs
Est. 180,500 USD
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and co…
Est. 188,500 USD
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and co…
Est. 237,500 USD
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, w…
Est. 330,500 USD
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 209,500 USD
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 237,500 USD
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 195,250 USD
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and co…
Est. 237,500 USD
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 237,500 USD
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 274,500 USD
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 239,300 USD
Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve…
Est. 190,000 USD
Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA…
Est. 250,000 USD
MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disea…
Est. 85,000 GBP
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 277,500 USD
Who We Are: Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that…
Est. 312,500 USD
About Beeline Medicines: Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and i…
Est. 200,000 USD
About Us Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is Kardigan’s mission to develop multiple targeted treatme…
Est. 172,500 USD
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team…
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 210,500 USD
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
Est. 295,000 USD
MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disea…
Est. 85,000 USD
ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to…
Est. 120,000 USD
COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, w…
Est. 298,000 USD
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 298,000 USD
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 327,641 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 209,500 USD
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 120,000 GBP
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…