Associate Director, Regulatory Strategy

Associate Director, Regulatory Strategy

Princeton, New Jersey, United States, South San Francisco, California, United States

Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is Kardigan's mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve. Led by Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan's co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020. We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients. At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals.

Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries. These values are the foundation of our work, empowering us to make a real difference, every day.

Position Title: Associate Director, Regulatory Strategy

Reports To: Executive Director, Regulatory

Department: Regulatory

Location: South San Francisco, CA or Princeton, NJ – On site 4 days a week (Mon to Thurs)

Job Overview

Reporting to the Executive Director, Regulatory, the Associate Director, Regulatory Strategy supports the development and execution of regulatory strategies and contributes to the planning, coordination, and preparation of regulatory submissions. This role collaborates cross-functionally to ensure high-quality regulatory deliverables while operating with moderate independence and with oversight on complex deliverables.

Essential Duties and Responsibilities

• Contribute to the development and implementation of regulatory strategies for assigned development programs, with guidance from senior leadership
• Demonstrated ability to operate with increasing independence while seeking guidance on complex strategic decisions
• Plan, coordinate, and contribute to the preparation, review, and compilation of regulatory submissions in eCTD format
• Lead or support preparation of components of submissions (e.g., Module 1–5 sections) for health authorities (FDA, EMA, and global agencies)
• Review key documents (e.g., protocols, ICFs, IBs, CSRs, DSURs) to ensure alignment with regulatory strategy and compliance with applicable regulations and guidance
• Track submission timelines and deliverables to support on-time execution
• Provide regulatory input to cross-functional teams (Clinical, CMC, Nonclinical, Quality) on regulatory requirements and expectations
• Identify regulatory risks and propose mitigation strategies for review by Regulatory leadership
• Maintain awareness of evolving regulatory requirements and guidance (FDA, EMA, ICH, and global regulations)
• Ensure assigned activities comply with applicable regulatory standards and company procedures
• Support the development and review of SOPs, work instructions, and regulatory templates

Qualifications and Preferred Skills

• Bachelor's degree required (life sciences preferred); advanced degree (MS, PhD, or PharmD) is a plus
• Minimum of 6 years of relevant experience including roles in regulatory affairs within biotechnology or pharmaceuticals
• Experience supporting regulatory submissions (e.g., INDs/CTAs, amendments, annual reports, or marketing applications)
• Working knowledge of global regulatory requirements (FDA, EMA, ICH guidelines)
• Experience contributing to or leading eCTD submissions
• Strong organizational skills and attention to detail with the ability to manage multiple priorities
• Effective communication skills and ability to work collaboratively in cross-functional teams
• Ability to communicate regulatory expectations pertaining to the drug development process, FDA/EMA/global guidance and regulations, to cross-functional teams

Exact Compensation may vary based on skills, experience and location.

Pay range $170,000 - $230,000 USD