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
Experienced Underwriting Insurance Professional
Experienced Underwriting Insurance Professional Location Rancho Cordova, CA : Who Are We? Taking care of our customers, our communities and each other. That's the Travelers Promise. By honoring this c…
Estate Planning Attorney
Shoup Legal is seeking a skilled Estate Planning Attorney to join our dynamic team. This role involves advising clients on estate planning, trust administration, and related legal matters to secure th…
Sales Enrollment Agent
Talentforge Solution- El Monte, a leading direct marketing firm based in California, is hiring a Sales Enrollment Agent for our telecommunications and technology campaign. This entry-level role is id…
Experiential Marketing Coordinator
EXPERIENTIAL MARKETING COORDINATOR ABOUT Slate At Slate, we've got one job: building a vehicle you'll fall in love with, right here in the USA. We believe that car buyers—not car companies—shoul…
Industrial Maintenance Mechanic Lead
Job Description Job Description The Maintenance Lead assigns work tasks to mechanics, assist Maintenance Supervisor with scheduling and monitoring workloads. Trains less experienced employees as …
Workers' Compensation Analyst- Telework Option
Job Description and Duties This position is eligible to telework up to three (3) days a week, in accordance with the Statewide Telework Policy, and will be required to report to the office as need…
Senior QA Engineer
Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in histo…
Java Fullstack Tech Lead (Java + VueJS)
We are hiring a Java Fullstack Tech Lead (Java + VueJS) for one of our clients in San francisco, CA Key Responsibilities Lead the technical design, architecture, and development of sca…
Full Time Family Practice Job Exeter, CA
OFH-102 Central Valley Community Health Network offers state-of-the-art Health Centers in Kern, Kings, Tulare, and Fresno Counties. Services include Medical, Women's Health, Dental, Behavioral…
Dishwasher
Job Description Job Description Benefits: Flexible schedule Free food & snacks Benefits/Perks Flexible Scheduling Competitive Compensation Career Advancement Opportunities Jo…