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Senior Director, Regulatory Affairs

2 months ago

cambridge, United States Apnimed Full time

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, including through Shionogi-Apnimed Sleep Sciences (SASS), a joint venture with Shionogi, Inc.


The Senior Director of Regulatory Affairs will play a key role in advancing innovative SASS programs through clinical trials and on to commercialization globally. The ideal candidate will possess strong clinical writing skills, a deep understanding of the United States and Japanese pharmaceutical regulatory systems, and a proven track record of successfully leading regulatory strategies across global markets. This position will report to the Chief Medical Officer, and may be based in Apnimed headquarters in Cambridge, Massachusetts, or based remotely with periodic travel.


Key Job Duties include, but are not limited to:


  • Lead the development and execution of regulatory strategies to support the approval and commercialization of Apnimed’s therapies globally.
  • Provide expert guidance on the U.S. pharmaceutical regulatory landscape to SASS, including Food and Drug Administration (FDA) processes, requirements, and guidelines.
  • Oversee the preparation, review, and submission of high-quality regulatory documents, including Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), and Common Technical Document (CTD) modules.
  • Establish and maintain relationships with regulatory agencies, actively participating in interactions and submissions to secure necessary approvals and licenses.
  • Partner with cross-functional teams within Apnimed and with our colleagues at Shionogi, including Clinical Development, Medical Affairs, Alliance Management, and Commercial to ensure regulatory requirements are integrated into product development plans.
  • Manage the preparation and submission of regulatory applications, including INDs, NDAs, and other relevant filings, ensuring compliance with U.S and global regulatory requirements.
  • Stay informed of the latest regulatory trends, changes, and best practices, particularly in the U.S. and Japan, and proactively adjust strategies to ensure compliance and competitive advantage.
  • Collaborate with the rest of the Apnimed Regulatory Affairs department to support Apnimed’s wholly owned programs.


Qualifications:


  • Bachelors’ degree in a healthcare-related discipline is required, and an advanced degree preferably in Regulatory Affairs is a plus.
  • Minimum of 10 years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry. Some experience in a rapidly growing company is preferred
  • Demonstrated knowledge in the Japanese regulatory environment.
  • Proven experience in clinical writing, with a strong portfolio of regulatory documents.
  • Track record of successful regulatory submissions and product approvals in the U.S.is required and other global markets would be is a plus.
  • Demonstrated ability to develop, execute and follow-through complex projects to completion.
  • Skilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
  • Independently motivated, detail oriented with strong problem-solving ability.
  • Excellent organizational skills and demonstrated ability to multi-task in a fast-paced environment with changing priorities.
  • Exceptional verbal and written communication skills, with the ability to translate complex scientific concepts into clear regulatory strategies and documents.
  • Proficiency in Japanese is a plus but not required.


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 Best Place to Work


Location and Other Information:


  • Apnimed is a privately held company based in Cambridge, MA; we are generally virtual, and a specific location within the US is flexible, but 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