Director, Regulatory Affairs

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 RESPONSONSIBILITIES: - 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).