Director, Regulatory Affairs

ABOUT MEDICINES360

At Medicines360, we are more than a women’s health innovation organization — we are a catalyst for change. We are fearless in our pursuit of creative approaches to solving consequential women’s health issues and transforming novel ideas into life-changing products that improve the lives of all women, and especially the underserved. We are fiercely dedicated to our mission of improving women’s health worldwide. Our launched products address pressing health concerns of women, providing them with the products they need to live healthier, more fulfilled lives.  For more information on Medicines360, please visit Medicines360.org

Position Title: Director, Regulatory Affairs

Reports To: Head of Regulatory Affairs and Quality Assurance

FLSA Status: Full-time, Exempt

Location: San Francisco – Hybrid

POSITION SUMMARY:

The Director, Regulatory Affairs provides strategic and operational leadership for the Regulatory activities of Medicines360 and its affiliates. S/he is responsible for developing and executing global regulatory strategies for a wide range of medical products (including drugs, drug-device combination products, medical devices, and IVDs) across their product lifecycles. Primary markets are the US, EU, UK, and low- and middle-income countries (LMICs). S/he is responsible for the development, submission, and maintenance of regulatory applications. S/he provides oversight of the regulatory team and its projects. S/he is responsible for ensuring compliance of all Medicines360 TMFs and DHFs, as well as other regulatory files and recordkeeping systems. S/he also serves as the primary back-up system administrator for Veeva RIM.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Develop and execute global regulatory strategies for multiple, complex regulatory projects involving cross-functional input and external partners
• Delivers high-quality regulatory submissions to agreed-upon project targets, by coordinating cross-functional teams to generate timely input
• Oversees the preparation, review, and approval of global regulatory submissions, including but not limited to:
  • Clinical investigation applications (e.g., INDs and IDEs) and their amendments
  • Marketing applications (e.g., NDAs, premarket notifications, De Novo Requests, CE Mark and/or UKCA Mark via Technical Files) and their amendments/supplements/variations
  • Post-marketing reports (e.g., PADERs and PSURs/PBRERs)
  • Requests for regulatory authority interactions (e.g., Type A/B/C meetings and Q-submissions) with supporting documentation
• Lead regulatory assessments for change management, including the review of data, development of regulatory reporting strategies, and risk assessment
• Ensures regulatory compliance of product labeling for investigational use and commercialization
• Provides regulatory guidance on clinical development programs, including protocols, SAPs, TMFs, and regulatory reporting
• Provides regulatory guidance on CMC strategies for drugs and drug-device combination products
• Provides regulatory guidance on medical device development programs, including management of DHFs
• Ensures regulatory compliance of promotional materials, coordinating regulatory submissions of materials when required
• Acts as primary author of regulatory documentation, leveraging subject matter experts as needed
• Ensures archival of regulatory files and records necessary to maintain compliance
• Manages relationships with external regulatory partners, including regulatory CROs and consultants
• Performs ongoing regulatory intelligence activities and integrates findings into regulatory strategies and activities:
  • Monitors, interprets, and disseminates current and changing regulatory legislation, guidance, and practices with relevant personnel
  • Monitors the women’s health and contraception industry for trends and relevant news, reporting to relevant personnel
• Contributes to drafting, reviewing, revising, and approving clinical, quality, and regulatory SOPs
• Serves as a member of new product development team by performing strategic regulatory due diligence of product candidates
• Leads the cross-functional regulatory inspection team, participating in regulatory inspections as the regulatory lead
• Manages and mentors regulatory personnel for career development and advancement
• Member of Pharmacovigilance (PV) Team; oversees the management of risk management plans, the CCDS, and product labeling
• System administrator and Subject Matter Expert for Veeva RIM

ESSENTIAL SKILLS & QUALIFICATIONS:

• A. or B.S. degree or equivalent qualification and experience
• Post-graduate degree strongly preferred
• RAC-Drugs and/or RAC-Device certification highly desirable
• Minimum 10 years related regulatory experience, preferably for both drugs and devices, including the successful preparation and submission of regulatory applications to stringent regulatory authorities including the US FDA
• Minimum 5 years in a management role
• Requires strong understanding of ICH guidelines, GXP principles, and US FDA regulations and guidelines
• Requires working knowledge and understanding of the global regulatory landscape, including EU, UK, and LMIC regulatory frameworks
• Requires strong organizational and technical skills (e.g. word processing, spreadsheets, databases, online research)
• Experience with Veeva QMS and/or RIM is desirable
• Requires excellent verbal, written, and communication skills
• Availability for travel, both domestic and international
• Ability to prioritize multiple assignments in a fast-paced office environment and communicate those priorities within the department, to leadership, and across cross-functional teams
• Ability to effectively communicate with and manage multiple external partners and teams, locally and globally, including availability for collaboration across multiple time zones
• Ability to work independently and as a team player cross-functionally
• Ability to effectively manage and lead the department and, when needed, cross-functional teams
• Ability to effectively develop a department and its personnel, including coaching and mentoring

IN OFFICE PRESENCE: Tuesday, Wednesday & Thursday

PHYSICAL DEMANDS/MISC:

• Must be able to remain in a stationary position 50% of the time.
• The person in this position may need to occasionally move throughout the office to attend meetings in different rooms.
• Continuously operates a computer and occasionally uses other office productivity machinery, such as copy machines, and computer printer.
• The ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in these situations.
• The ability to observe details at close range (within a few feet of the observer).

Medicines360 is committed to a diverse workplace and to equal opportunity employment for all job applicants, regardless of race, color, religion, sex, sexual orientation, age, gender identity or expression, national origin, disability, or veteran status. Medicines360 complies with all applicable local, state, and national laws governing nondiscrimination in employment.