Senior Director, Regulatory Affairs

Altasciences•Overland Park, KS

13d•$150,000 - $200,000

About The Position

The Senior Director, Regulatory Affairs is a strategic and operational leader responsible for overseeing regulatory strategy, execution, and compliance across all phases of drug development but with a primary focus on early-stage first-in-human / first-in-class molecules. This role ensures alignment with business goals, regulatory requirements, and evolving industry standards. The Senior Director will lead a team of Regulatory Affairs professionals and serve as the primary liaison with global health authorities, including the FDA, EMA, and Health Canada.

Requirements

10 years’ experience in regulatory affairs in a CRO, biotechnology or pharmaceutical setting.
Demonstrated success in leading early-stage regulatory strategy and submissions in North America (FDA and Health Canada) for a variety of indications and molecules.
Deep knowledge of Health Canada and FDA regulatory frameworks, including CTA and IND processes.
Excellent scientific and business judgment.
Proven track record practicing sound judgment as it relates to risk assessment.
Understanding of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
Understanding of where to seek and how to interpret regulatory information.
Excellent verbal and written communication skills.
Professional attitude and strong interpersonal skills.
Ability to work well with a multi-disciplinary team of professionals.

Nice To Haves

PhD in related discipline preferred.

Responsibilities

Partner with business development to identify and hold initial conversations with potential clients (focusing on clients at the end of the discovery phase).
Consult with client pre-award to determine regulatory requirements to meet program needs.
Define and prepare regulatory strategy plans.
Create, present, and defend content for proposals.
Build, mentor, and manage a high-performing regulatory team.
Serve as a point of contact for regulatory questions and oversee interactions with regulatory agencies, ensuring effective communication and constructive working relationships with regulatory authority representatives.
Partner with Clinical, CDMO, Nonclinical, Medical Writing, and Project Management teams to ensure integrated regulatory planning and execution.
Lead the preparation for regulatory meetings (pre-Investigational New Drug Application [IND], pre-Clinical Trial Application [CTA]).
Oversee regulatory submission requirements and provide content for regulatory submissions.
Implement SOPs and best practices to enhance efficiency and compliance.
Monitor the development of new regulatory requirements or guidance documents and advise on the impact on the business or development programs.
Identify overall risks to regulatory plans in conjunction with project teams and participate in mitigation strategy team.