Senior Director, Regulatory Operations

Kardigan•Princeton, NJ

3d•Onsite

About The Position

Kardigan is seeking an experienced Senior Director, Regulatory Operations. Reporting directly to the SVP of Regulatory, the Senior Director will oversee global Regulatory Operations across Kardigan’s portfolio. This role is responsible for end-to-end management of global regulatory submissions, ensuring timely and compliant publishing, electronic submission and archival. The Senior Director will partner closely with Regulatory and cross-functional team members to deliver high quality, inspection ready submissions aligned with corporate objectives. This role will ensure or establish best practices for Regulatory Operations.

Requirements

Bachelor’s degree in a scientific, life sciences, or related field required.
10+ years of relevant industry experience, with majority of experience in Regulatory Operations.
Demonstrated experience leading global regulatory submissions across multiple regions.
Experienced in building and leading teams and managing outsourced partners.
Strong experience with eCTD publishing, regulatory systems (e.g., RIM), and regulatory document management.
Experience driving regulatory operations transformation or system implementations.
Deep understanding of global regulatory submission requirements and health authority expectations.
Strategic thinker with strong execution, problem solving, and change management skills.
Excellent communication, collaboration, and stakeholder management abilities.
Strong organizational and project management skills with high attention to detail.
Ability to operate effectively in fast paced, evolving environments while maintaining quality and compliance.

Nice To Haves

Advanced degree (MS, PhD, PharmD) preferred.
Experience supporting late stage development and regulatory inspections preferred.

Responsibilities

Oversee all regulatory submission types (eg, IND, CTA, NDA, MAA, and amendments) across Kardigan’s portfolio.
Manage planning, publishing, electronic submission, and archival of regulatory submissions.
Establish clear lines of communication with stakeholders to align regulatory plans that maximize efficiency and quality of regulatory submissions.
Build, mentor, and manage a high-performing Regulatory Operations team, including contractors and vendors, to achieve overall corporate objectives.
Manage external vendors, CROs, and consultants for performance and budget.
Set clear goals and expectations, supporting continuous improvement and accountability.
Support cross-functional employee on-boarding and training by providing technical support to stakeholders and project team members as needed.
Support Regulatory budgeting and forecasting activities, including review of expenditures for activities related to vendor contracts.
Maintain and enhance regulatory systems and tools (RIM, publishing, document management, templates and relevant style guides).
Partner with IT/business teams on validation and upgrades.
Develop and implement SOPs and standardized processes, drive process optimization.
Ensure operational compliance with global regulations and internal policies.
Lead inspection readiness, training, and documentation oversight.
Monitor regulatory changes and assess their impact.