Vice President, Regulatory Affairs and Quality Assurance

Apnimed is a well-funded, clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our lead development program targets the neurologic control of upper airway muscles to maintain an open airway during sleep. Based in Cambridge, Mass., we are developing a portfolio of novel pharmacologic therapies for sleep apnea and related disorders. The Vice President, Regulatory Affairs and Quality Assurance reports to the President and will drive Apnimed’s regulatory and quality assurance efforts for pharmaceutical products and sleep monitoring devices. The successful candidate will also play a key role in partnering with other leaders across Apnimed to develop and drive our company strategy and culture. This is an exciting opportunity to develop and implement the regulatory affairs strategy that will drive major paradigm shifts in the treatment of sleep apnea from medical devices and surgery to a first-in-class pharmaceutical treatment. Key Job Duties include, but are not limited to: Develop and execute a comprehensive regulatory strategy to enable rapid approval of lead and pipeline therapeutics that promise to revolutionize the treatment of sleep apnea Lead and manage the NDA submission process by coordinating the efforts of cross-functional internal teams with external services to ensure timely submissions and compliance with FDA and global regulatory requirements Establish and maintain relationships with regulatory agencies, actively participating in interactions and submissions to secure necessary approvals and licens Support the regulatory approval of an innovative wearable sleep/breathing device that supports the diagnosis, therapy initiation and monitoring of sleep apnea treatments including Apnimed’s therapeutics Provide senior leadership, collaboration and management of Regulatory Affairs including Regulatory Strategy, Regulatory CMC, Regulatory Operations, Advertising and Promotion and Labeling Provide oversight of the QC/QA team to ensure operations and procedures adhere to ICH and other pertinent standards, align with industry best practices, and regulatory inspection readiness Monitor and stay informed about evolving regulatory requirements, proactively adapting Apnimed’s policies, processes and procedures to maintain compliance Lead efforts to establish and maintain a culture of quality excellence throughout the organization, with a focus on continuous improvement and risk mitigation. Education and Experience: A Bachelor's degree in a relevant scientific field or equivalent is required; advanced degrees such as a Master's or Ph.D. in a related discipline is highly desirable A minimum of 15 years of experience in regulatory affairs in positions of increasing responsibility is required Proven experience in leading quality assurance and quality control programs, including cGMP, cGCP, and ICH standards Strong executive leadership track record with the ability to motivate and manage remote teams effectively Extensive hands-on experience in the development of key regulatory submissions, including NDAs, BLAs, MAAs, and INDs, as well as interacting with regulatory authorities and supporting site/sponsor regulatory inspections An NDA filing is planned in the next 12 months, so experience preparing, filing and seeing multiple NDAs through approval and preparing for advisory committee meetings is highly desirable Experience leading global regulatory organizations through critical product milestones to and beyond commercial approval, preferably with some experience involving novel regulatory strategies and novel treatment modalities Experience working with QA and QC functions and SOP development, inspection readiness and regulatory inspections Experience in the medical device and diagnostics industry approval process is a plus Experience collaborating with Commercial, Medical, and Legal for development and review of labeling, advertising and promotional materials, ensuring compliance with corporate policy, and all relevant laws and regulations is strongly preferred In-depth knowledge of US and international regulatory frameworks and standards relevant to sleep medicine is highly desirable Demonstrated leadership role in the regulatory field, as demonstrated by activities such as professional meeting presentations, position papers or other types of publications, or involvement in professional or educational organizations strongly preferred. What Apnimed Offers: 401(k) with company match Generous time off for vacation Generous healthcare benefits Flexible working environment Motivated and experienced team Winner of 2024 Boston Business Journal Best Places to Work Location and Other Information Apnimed is a privately held company based in Cambridge, MA; we are generally virtual and specific location within the US is not critical. We are a small growing Company with an inclusive environment. We are pioneering exciting treatments for sleep apnea and were selected as a member of the 2023 Fierce 15 Must be able to travel, as necessary. Apnimed is an EEO employer committed to an exciting, diverse, and enriching work environment. Please visit us at www.apnimed.com to learn more about our work with Obstructive Sleep Apnea.