Senior Director Regulatory Strategy

A cuttingedge biotechnology company is seeking a Senior Director, Regulatory Affairs to lead global regulatory strategy across a portfolio of innovative, highimpact programs. This team is composed of world-class scientists and innovators who are leading the charge on integrating advanced imaging and AI technologies to revolutionize drug discovery

The Senior Director, Regulatory Affairs will oversee the design and execution of regulatory strategies from early development through registration, ensuring alignment with U.S. and international requirements. The ideal candidate will bring deep expertise in global regulatory pathways, exceptional leadership in crossfunctional settings, and the ability to provide strategic guidance across R&D, Clinical, and Quality functions while serving as a key liaison with regulatory authorities.

Responsibilities:

• Develop and execute comprehensive regulatory strategies supporting development, approval, and commercialization.
• Ensure alignment of regulatory plans with corporate objectives and clinical development goals.

• Maintain deep awareness of evolving U.S. and global regulations, guidelines, and industry standards.
• Ensure all company activities and programs adhere to applicable regulatory requirements.

• Oversee the preparation, review, and delivery of regulatory submissions such as INDs, NDAs, BLAs, and MAAs.
• Ensure submission packages are scientifically sound, strategically positioned, and delivered on time.

• Partner closely with Clinical Development, Research, Quality, CMC, and other key stakeholders to integrate regulatory considerations into development programs.
• Provide clear, proactive regulatory guidance across program teams.

• Support regulatory aspects of quality systems, including adherence to GCP, GLP, and other relevant standards.
• Ensure inspection readiness and alignment with regulatory expectations.

• Identify regulatory risks and develop mitigation strategies across programs and functions.
• Anticipate potential regulatory challenges and proactively guide teams toward solutions.

Qualifications

• Postgraduate degree with 12+ years of regulatory affairs experience, or bachelor's degree with 15+ years of relevant experience.
• Prior experience as a people manager is a requirement
• Extensive knowledge of FDA and global regulatory requirements and guidelines.
• Proven experience supporting regulatory strategy across all stages of the product lifecycle
• Oncology experience is a plus
• Proven leadership experience in developing and executing regulatory strategies.
• Strong communication, negotiation, and crossfunctional partnership skills.
• Analytical, detailoriented, and solutionsfocused, with the ability to operate in a fastpaced environment.
• Demonstrated adaptability and readiness to lead in a highgrowth, innovationdriven setting.