Director of Regulatory Affairs (San Francisco, CA)
This role provides global regulatory leadership and expertise to ensure compliance and successful submission of clinical regulatory filings. The position involves developing regulatory strategies, managing submissions, and maintaining communication with regulatory agencies and project teams.
Lead global regulatory activities and strategy development for clinical regulatory filings.
Oversee the preparation, review, and submission of regulatory documents, including INDs and FDA submissions.
Guide project teams in interpreting and communicating regulatory requirements.
Manage interactions with regulatory agencies and coordinate responses to inquiries.
Monitor and assess the impact of global regulations on programs.
Coordinate with CROs and consultants to ensure regulatory deliverables are met.
Necessary Experience:
Education: BA/BS degree in biological or physical sciences preferred.
Regulatory Experience: Minimum of 6 years in a relevant regulatory role.
Skills and Competencies:
Strong written, oral, and interpersonal communication skills.
Attention to detail with the ability to organize and prioritize tasks.
Proficient in MS Office and experience with document management systems.
Ability to work effectively in a fast-paced and dynamic environment.
Preferred Experience:
Experience working with CROs for US eCTD IND submissions and ex-US CTAs.
Department: Direct Clients
This is a full time position
Recommended Jobs
Plumber
Yellowstone Local is proud to represent EcoWater SoCal, an industry leader in residential and commercial water treatment solutions. Sick of running pipe for the same worn-out projects? Come do w…
Construction Repair Technician
Elevate Your Career with Advanced IPM: Join Our Growing Team! Are you seeking an opportunity to advance your career in a family-owned company that truly values its employees? Do you want to make a me…
Physical Therapy Clinical Specialist Fellowship Spine or Sports
Job Summary: Under indirect supervision the clinical specialist staff fellow designs treatment programs and acts as a resource and mentor to students and staff in their area of clinical specialt…
Service Manager
Requisition Number: 217082 Job Description Cintas is seeking a Service Manager to directly manage our customer facing Service team. Responsibilities include hiring and performance management; …
Merchandiser - NO NIGHTS OR WEEKENDS
Merchandiser Our merchandisers are the heart and soul of Jacent. They're on the front lines in more than 17,000 stores placing just the right products, building displays, and working with store pe…
Regional Print Estimator (Los Angeles)
Position Title: Regional Print Estimator Description Regional Estimator Location: Riot Creative Imaging Los Angeles Office Team: Southern California Operations (local and national pr…
Product Manager, Fintech - Sacramento, 95814
Product Manager, Fintech - Sacramento, 95814, United States of America How we LEAD: We're looking for a strategic, analytical, and highly collaborative Product Manager, Fintech to drive the dev…
CNC Operator
Description Kickstart Your Career as a CNC Operator! Location: Fresno, CA Pay: Starting at $18.00–$21.00 per hour (based on experience) About the Role We’re looking for motivated individuals to…
AI & Electrical Engineering Intern (Bali)
AI & Electrical Engineering Intern (Bali) Location: Bali, Indonesia (On-site only) Compensation: Unpaid Internship Role Overview Work at the cutting edge of sustainable technology on AI-inte…
Software Engineer, BCI Applications
About Neuralink: We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolut…