Senior Director, Regulatory Strategy

About Us

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 our mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.

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: Director or Senior Director, Regulatory Strategy

Department: Development

Reports To: SVP. Regulatory Affairs

Job Overview

Reporting to the Head of Regulatory Affairs, The Director, Regulatory Strategy responsibilities will include planning, coordination, review, and assembly of regulatory documentation for submission to health authorities (e.g., FDA and global regulatory agencies). The primary job functions include, but are not limited to, the following

Essential Duties and Responsibilities

• Planning, coordination, review, and assembly of regulatory documentation for submission to health authorities (e.g., FDA, EMA, and other global regulatory agencies) Independently or with limited oversight, plan, compile, review, and submit documents for the company, including but not limited to initial INDs/CTAs/NDAs/MAAs and amendments or supplements
• Provide regulatory direction to project teams in developing and implementing regulatory strategies and plans Develop, maintain, and communicate timelines for regulatory submissions to ensure timely delivery of regulatory documentation
• Participate in the review of critical documents such as: protocols, ICFs, IBs, CSRs, DSURs, etc. to ensure they are compliant with relevant regulations and guidance (e.g. ICH, FDA, EMA, etc.) prior to submission
• Coordinate with vendors to appropriately plan and finalize submissions to health authorities in accordance with regulations and guidelines
• Maintain regulatory databases, including submission and correspondence logs Independently plan daily work to complete time sensitive assignments
• Review, write, and present guidelines and SOPs as needed to support high-quality submissions and assure adherence to regulatory requirements
• Maintain current knowledge of applicable US and global regulations, guidance, and standards for drug development and product registration

Qualifications and Preferred Skills

• A minimum of a bachelor's degree is required (life sciences disciplines strongly preferred) with approximately 8 years of experience in the biotechnology or pharmaceutical industries in regulatory affairs or related functions in drug/biologics development/manufacturing (an equivalent combination of education and experience may be considered).
• Great attention to detail, ability to work on multiple projects with tight deadlines, and ability to work independently.
• Demonstrated experience leading eCTD formatted submissions, e.g., INDs, NDAs/BLAs, MAAs, annual reports, amendments, and supplements for drugs and/or biologics.
• Has successfully led responses to health authorities or other critical submissions while maintaining agreed timelines
• 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

$198,000-$260,000 USD