Executive Director, Regulatory Affairs

Executive Director/Senior Director, Regulatory Affairs (Global) – Oversight of IND/IMPD, BLA, and ex-US activities for CAR-T and immunotherapy products.

Responsibilities:
- Lead cross-functional teams for eCTD submissions and responses to Health Authority questions.
- Develop, review, and approve submissions and responses aligned to global regulatory strategy and timelines.
- Communicate regulatory strategy, risks, and plans to SVP Regulatory and internal teams.
- Lead regulatory interactions, issue resolution, and negotiations for approvals across regions.
- Partner with multidisciplinary leads on submission planning and project/product information exchange.
- Monitor and influence changes in the global regulatory environment aligned to business needs.
- Define and communicate internal/external regulatory resourcing needs to SVP RA.
- Coach, mentor, and develop assigned team members.

Qualifications/Experience:
- Master’s or PhD in Life Sciences, Biotechnology, or relevant Pharmaceutical Science.
- Minimum 5 years progressive pharmaceutical industry/regulatory authority experience, including biologics.
- Leadership delivering marketing authorizations, clinical trial applications, and post-approval submissions for CAR-T/gene therapy.
- People development/management experience.
- Proven global regulatory strategy execution; competency in planning and managing high-complexity, high-risk projects.

Desired Key Competencies/Skills:
- Strong analytical decision-making and attention to detail.
- Excellent organization/time management; ability to handle multiple complex projects.
- Proactive problem-solving; clear oral/written communication.
- Ability to coordinate stakeholders and demonstrate strong ethics and trustworthiness.