Associate Director, Regulatory Strategy

Kardigan•Princeton, NJ

4h•$170,000 - $230,000•Onsite

About The Position

Kardigan is a heart health company dedicated to making cardiovascular disease preventable and curable. The company aims to develop multiple targeted treatments in parallel to address cardiovascular diseases. Founded by leaders who previously developed mavacamten, Kardigan possesses a strong discovery and research platform, a pipeline of late-stage candidates, and a driven team focused on patient well-being. The company's values emphasize patient-centricity, authenticity, continuous learning, teamwork, and enabling the impossible through innovation and risk-taking.

Requirements

Bachelor’s degree required (life sciences preferred).
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.

Nice To Haves

Advanced degree (MS, PhD, or PharmD) is a plus.

Responsibilities

Contribute to the development and implementation of regulatory strategies for assigned development programs, with guidance from senior leadership.
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.