Vice President, Regulatory Affairs

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 reports to the President and will lead Apnimed’s global regulatory strategy for pharmaceutical products and sleep monitoring device. 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 shift 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 could 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 licenses;
• 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;
• Monitor and stay informed about evolving regulatory requirements, proactively adapting Apnimed’s processes and procedures to maintain compliance;
• Works closely with the QC/QA team to ensure operations and procedures adhere to ICH and other pertinent standards and regulatory inspection readiness;
• 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;
• 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 in the medical device and diagnostics industry approval process is a plus;
• Experience working with QA and QC functions and SOP development, inspection readiness and regulatory inspections 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;
• Demonstrated excellent written and oral communication skills;
• Exceptional and creative problem-solving and decision-making capabilities in complex, highly regulated environments;
• Highly organized with excellent project management skills;
• Proficiency in the use of MS Word, PowerPoint; experience with Adobe Acrobat Professional.

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.