Executive Director, Regulatory Strategy

Kardigan•Princeton, NJ

About The Position

Kardigan is seeking an Executive Director, Regulatory Strategy to lead global regulatory strategy across our portfolio of investigational cardiovascular therapies. Reporting to the SVP, Regulatory Affairs, this leader will serve as the regulatory lead on program teams, own the development and execution of regulatory strategy in line with the integrated development plan for late-stage clinical programs, and act as the primary interface with the U.S. Food and Drug Administration while directing ex-US regulatory activities with support from consultants, vendors, and partners. This is a high-ownership role in a fast-paced, entrepreneurial environment. The Executive Director will help define regulatory pathways for investigational therapies, including in indications without established regulatory precedent, and will help build Kardigan’s regulatory capabilities, processes, and team as the portfolio matures. Early priorities include refining program regulatory strategies and health authority engagement plans, establishing regulatory risk registers and regulatory intelligence monitoring, contributing to core regulatory processes and infrastructure, and managing the consultants and vendors supporting the portfolio. Significant regulatory strategy decisions and major agency positions will be developed in partnership with, and subject to alignment with, the SVP, Regulatory Affairs and the Executive Leadership Team.

Requirements

Bachelor of Science in a scientific discipline.
Minimum of 10 years’ experience in pharmaceutical regulatory activities, with experience as a leader accountable for global regulatory product strategy.
Extensive experience developing and implementing complex regulatory strategies, leading and managing regulatory teams, regulatory submissions (INDs, NDAs, and MAAs), product lifecycle management, and Health Authority interactions.
Matrix leadership: proven ability to lead cross-functional teams across clinical, regulatory, biometrics, data management, clinical operations, and commercial driving alignment on a unified development plan while safeguarding scientific and analytical integrity.
Must have excellent verbal and written communication skills, demonstrating the ability to communicate complex ideas in an easily understandable way.
Hands-on professional capable of working collaboratively and independently.
Excellent planning, organization and time management skills, including the ability to support and prioritize multiple projects.
Demonstrated management experience, including leadership and development of employees.
Current and strong working knowledge of regulatory requirements including GxP, eCTD submission standards, and ICH guidelines.

Nice To Haves

Advanced degree in a scientific discipline.

Responsibilities

Lead the development and execution of the regulatory strategy in line with the integrated development plan for late-stage clinical programs, ensuring alignment with corporate objectives and applicable global regulatory requirements.
Interface with internal and external stakeholders to develop and implement cross-portfolio global regulatory strategies in line with business objectives.
Serve as the primary point of contact with the FDA — including meeting requests, briefing materials, day-to-day correspondence, and responses to information requests — and direct ex-US regulatory activities with support from consultants, vendors, and partners.
Lead preparation and execution of formal health authority meetings (e.g., Type B/C, End-of-Phase 2, and pre-NDA/pre-MAA meetings), including briefing documents and cross-functional rehearsals.
Independently contribute to and/or oversee the planning, compilation, review, approval, and submission of regulatory documents, including initial INDs/CTAs/NDAs/MAAs and amendments or supplements, meeting packages, expedited-program and designation requests where supported by the data (e.g., Breakthrough Therapy, Fast Track), annual reports, and Investigator’s Brochures.
Ensure regulatory documents and submissions are accurate, complete, verifiable, and compliant with applicable FDA, ICH, and global requirements, and that regulatory databases, submission logs, and correspondence logs are maintained.
Provide quality regulatory input and strategic perspective across all stages of drug development — including clinical development plans, protocol design, endpoint strategy, and evidence-generation planning — to support informed decision-making and optimize the company’s regulatory approaches for product development and lifecycle management.
Lead development and maintenance of the labeling strategy, partnering with Clinical Development, Medical Affairs, and Commercial to align on the evidence required to support them and to prepare the organization for labeling discussions with health authorities.
Partner closely with Regulatory CMC to ensure alignment of overall development strategies and integrated, submission-ready regulatory content.
Identify and assess regulatory risks associated with development programs and define approaches to mitigate them; communicate risk assessments, scenario planning, and mitigation strategies to program teams, the SVP, Regulatory Affairs, and the Executive Leadership Team, surfacing risks early with clear, well-reasoned recommendations.
Directly oversee regulatory responsibilities outsourced to CROs, consultants, and vendors, ensuring quality, strategic alignment, and compliance with applicable regulations and guidelines; provide regulatory due diligence and strategic input for business development opportunities as needed.
Review, write, and present guidelines and SOPs as needed to support high-quality submissions and ensure cross-functional adherence to regulatory requirements.
Maintain current knowledge of applicable US and global regulations, guidance, and standards for drug development and product registration; monitor, interpret, analyze, and disseminate regulatory intelligence that may affect ongoing development.
Hire, develop, and mentor regulatory professionals, fostering accountability and a culture of collaboration.