Director, Regulatory Affairs

Medicines360

. Develop and execute global regulatory strategies for complex regulatory projects involving cross-functional teams and external partners .

Posted 10/22/2026full-timeSan Francisco • California • United StatesLead💰 $200,000 - $225,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive regulatory expertise with a strong focus on developing and executing global regulatory strategies for drugs and devices, ensuring compliance with ICH guidelines and US FDA regulations. Proven ability to lead cross-functional teams, manage regulatory submissions, and mentor personnel in a fast-paced environment.

Highest-signal resume keywords

Regulatory Strategy DevelopmentRegulatory Submissions ManagementICH Guidelines UnderstandingRAC-Drugs CertificationVeeva RIM System Administration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Documentation AuthoringClinical Investigation ApplicationsMarketing ApplicationsRisk AssessmentData ReviewRegulatory CompliancePharmacovigilance Risk ManagementChange ManagementRegulatory Due DiligenceSOP Development

Soft Skills

Excellent Communication SkillsOrganizational SkillsTeam CollaborationMentoringPrioritization

Tools & Technologies

Veeva QMSVeeva RIMDatabasesSpreadsheetsWord Processing

Certifications & Qualifications

RAC-DrugsRAC-Device

Industry Keywords

Global Regulatory LandscapeUS FDA RegulationsGXP PrinciplesClinical Development ProgramsWomen’s Health Industry Trends

About the role

Key responsibilities & impact

Develop and execute global regulatory strategies for complex regulatory projects involving cross-functional teams and external partners
Coordinate cross-functional teams to deliver high-quality regulatory submissions on project targets
Oversee preparation, review, and approval of clinical investigation applications, marketing applications, post-marketing reports, and regulatory authority interaction requests
Lead regulatory assessments for change management, including data review, reporting strategies, and risk assessment
Ensure compliance of product labeling for investigational use and commercialization
Provide regulatory guidance on clinical development programs, CMC strategies, medical device development, DHFs, and promotional materials
Author regulatory documentation and leverage subject matter experts as needed
Ensure archival of regulatory files and records
Manage relationships with regulatory CROs, consultants, and other external partners
Monitor, interpret, and disseminate regulatory legislation, guidance, practices, and women’s health industry trends
Contribute to clinical, quality, and regulatory SOP development and approval
Perform regulatory due diligence for new product candidates
Lead cross-functional regulatory inspection teams and participate as regulatory lead
Manage and mentor regulatory personnel
Oversee pharmacovigilance risk management plans, CCDS, and product labeling
Serve as Veeva RIM system administrator and subject matter expert

Requirements

What you’ll need

A. or B.S. degree or equivalent qualification and experience
Minimum 10 years related regulatory experience, preferably for both drugs and devices, including successful preparation and submission of regulatory applications to stringent regulatory authorities including the US FDA
Minimum 5 years in a management role
Strong understanding of ICH guidelines, GXP principles, and US FDA regulations and guidelines
Working knowledge and understanding of the global regulatory landscape, including EU, UK, and LMIC regulatory frameworks
Strong organizational and technical skills, including word processing, spreadsheets, databases, and online research
Excellent verbal, written, and communication skills
Availability for domestic and international travel
Ability to prioritize multiple assignments in a fast-paced office environment
Ability to communicate and collaborate with external partners and teams across multiple time zones
Ability to work independently and cross-functionally as a team player
Ability to manage and lead departments and cross-functional teams
Ability to develop departments and personnel, including coaching and mentoring
RAC-Drugs and/or RAC-Device certification highly desirable
Experience with Veeva QMS and/or RIM desirable

Benefits

Comp & perks

Hybrid work arrangement
In-office presence Tuesday, Wednesday & Thursday