Director of Regulatory Affairs
About The Position
The Director, Regulatory Affairs provides strategic and operational leadership for regulatory activities at Medicines360 and its affiliates. The role develops and executes global regulatory strategies throughout the lifecycles of drugs, drug-device combination products, medical devices, and in vitro diagnostic products, with primary markets in the United States, European Union, United Kingdom, and low- and middle-income countries. The Director oversees regulatory applications and submissions, the regulatory team and its projects, compliance of Trial Master Files (TMFs), Device History Files (DHFs), and other regulatory records, and serves as the primary backup system administrator for Veeva RIM. The position reports to the Head of Regulatory Affairs and Quality Assurance. It is a full-time, exempt role based in San Francisco with a hybrid work arrangement and required in-office presence Tuesday through Thursday. The Director also leads regulatory inspection activities, manages and mentors regulatory personnel, participates in the Pharmacovigilance team, and serves as a Veeva RIM system administrator and subject matter expert.
Requirements
- A. or B.S. degree or equivalent qualification and experience.
- At least 10 years of related regulatory experience, preferably covering both drugs and devices, including successful preparation and submission of applications to stringent regulatory authorities such as the US FDA.
- At least 5 years of experience in a management role.
- Strong understanding of ICH guidelines, GXP principles, and US FDA regulations and guidelines.
- Working knowledge of the global regulatory landscape, including EU, UK, and LMIC frameworks.
- Strong organizational and technical skills, including word processing, spreadsheets, databases, and online research.
- Excellent verbal, written, and communication skills.
- Ability to prioritize multiple assignments in a fast-paced office environment and communicate priorities within the department, to leadership, and across cross-functional teams.
- Ability to communicate with and manage multiple external partners and teams locally and globally, including collaboration across time zones.
- Ability to work independently and collaboratively across functions.
- Ability to lead and manage the department and cross-functional teams when needed.
- Ability to develop department personnel, including through coaching and mentoring.
- Availability for domestic and international travel.
Nice To Haves
- Post-graduate degree strongly preferred.
- RAC-Drugs and/or RAC-Device certification highly desirable.
- Experience with Veeva QMS and/or RIM is desirable.
Responsibilities
- Develop and execute global regulatory strategies for complex projects, coordinating cross-functional teams and external partners.
- Coordinate timely cross-functional input to deliver high-quality regulatory submissions against project targets.
- Oversee preparation, review, and approval of clinical investigation applications and amendments; marketing applications and amendments, supplements, or variations; post-marketing reports; and regulatory authority interaction requests and supporting documents.
- Lead regulatory assessments for change management, including data review, regulatory reporting strategies, and risk assessments.
- Ensure regulatory compliance of product labeling for investigational use and commercialization.
- Provide regulatory guidance on clinical development programs, including protocols, statistical analysis plans, TMFs, and regulatory reporting.
- Provide regulatory guidance on CMC strategies for drugs and drug-device combination products.
- Provide regulatory guidance on medical device development programs, including management of DHFs.
- Ensure promotional materials comply with regulatory requirements and coordinate submissions when required.
- Author regulatory documentation, engaging subject matter experts as needed.
- Ensure regulatory files and records are archived as required for compliance.
- Manage relationships with external regulatory partners, including regulatory CROs and consultants.
- Conduct regulatory intelligence activities; monitor, interpret, and share regulatory developments and relevant women’s health and contraception industry trends.
- Contribute to drafting, reviewing, revising, and approving clinical, quality, and regulatory SOPs.
- Perform strategic regulatory due diligence on product candidates as a member of new product development teams.
- Lead the cross-functional regulatory inspection team and participate in inspections as the regulatory lead.
- Manage and mentor regulatory personnel to support their career development and advancement.
- Participate on the Pharmacovigilance team and oversee risk management plans, the CCDS, and product labeling.
- Serve as Veeva RIM system administrator and subject matter expert.
- Travel domestically and internationally as needed.
- Prioritize multiple assignments, communicate priorities across teams, and collaborate effectively with internal and external teams across time zones.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
