Director, Regulatory Affairs

Iambic Therapeutics, Inc • San Diego, CA

1d • Onsite

About The Position

The Director of Regulatory Affairs will provide strategic leadership and hands-on execution for global regulatory activities across all development programs, guiding regulatory strategies and ensuring high-quality, timely filings aligned with corporate objectives and regulatory requirements. This role leads planning, creation, review, oversight and execution of complex submissions (e.g., INDs, DSURs, CTAs, Meeting requests, Briefing packages) in close collaboration with cross-functional partners including Clinical, Medical, CMC, Nonclinical, Safety, Translational and Quality functions, while maintaining consistency and adherence to internal standards. The position represents the company with global health authorities, builds strong relationships, and consolidates regulatory intelligence by monitoring evolving guidance and industry initiatives. The ideal candidate holds an advanced degree, brings 8+ years of pharma/biotech regulatory experience, and demonstrates exceptional communication, writing/editing, organization, attention to detail, and strong working knowledge of global regulations and guidelines (e.g., FDA, ICH)
This job is based in our San Diego headquarters

Requirements

• BS in a scientific discipline, with 15 years of experience OR Advanced Degree or equivalent with 10 years of experience in the regulatory field
• Independent, self-directed, and highly motivated regulatory professional.
• Ability to translate regulatory requirements into practical workable plans
• Diverse experience with regulatory activities including creation of systems and processes to support efficient and high-quality submission of documents to regulatory bodies.
• Strong organizational skills that reflect the ability to perform and prioritize multiple tasks with excellent attention to detail.
• Ability to build strong relationships with co-workers and vendors of various backgrounds and expertise.
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.
• Effective interpersonal and communication skills; must be a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems.
• Strong knowledge of regulatory software and tools, high proficiency in MS office

Nice To Haves

• Experience working in small and mid-sized biopharmaceutical companies is highly desirable.

Responsibilities

• Provide strategic input on regulatory activities, support strategic direction and coordinate regulatory submissions for Iambic’s development programs and planning
• Deliver high quality and timely regulatory submissions aligned with corporate goals, and in compliance with all applicable regulatory requirements
• Coordinate and collaborate activities across functions both within Iambic, and with external contract and business partners, including Clinical, Medical, CMC, Nonclinical, Safety, Translational and Quality functions
• Responsible for the creation, assembly, review and oversight of complex regulatory submissions to ensure program execution
• Ensure consistency, completeness and adherence to standards for all regulatory submissions
• Represent Iambic to develop and maintain strong relationships with the US FDA and other global regulatory agencies and partners
• Grow corporate, project and team knowledge by reviewing and analyzing current regulatory practice, guidance, and initiatives, communicating findings internally and developing actionable plans
• Develop and review standard operating procedures to ensure compliance with current regulatory requirements
• Support fit-for-purpose planning of the regulatory and quality functions evaluating contract support, software, and headcount
• Ability to run multiple workstreams, manage timelines, and deliver under tight deadlines with high quality
• Perform all duties while maintaining strong alignment with Iambic’s core values, policies, and all applicable regulations

Benefits

• We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life insurance, 401K matching, and uncapped vacation to our team.
• We are in a brand-new state-of-the-art facility in beautiful San Diego, with an on-site gym, dining, and easy access to great places to live and play.

What This Job Offers

• Job Type: Full-time
• Career Level: Director