Director, Regulatory Affairs

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Act as the regulatory lead for designated oncology programs, formulating and executing regulatory strategies from First-in-Human (FIH) trials through to post-marketing phases.

• Offer regulatory insights to clinical and development teams to ensure cohesive strategic alignment across various functions.

• Track and analyze global regulatory trends, conveying potential impacts on programs to senior leadership.

• Oversee the preparation and submission of Investigational New Drug applications (INDs), New Drug Applications (NDAs), and other regulatory documents.

• Ensure that submissions maintain high quality, compliance, and align with global regulatory standards.

• Provide operational oversight for the preparation, review, and delivery of submissions.

• Collaborate with teams in Clinical Development, Clinical Operations, Quality, and CMC.

• Advise project teams and senior management on regulatory matters.

• Represent the Regulatory Affairs department in both internal and external meetings, including discussions with regulatory agencies.

• Guide and mentor staff within Regulatory Affairs.

• Evaluate team resources and project priorities to guarantee timely achievement of key milestones.

• Foster a collaborative, solutions-focused culture within the Regulatory Affairs team.

• Contribute to initiatives aimed at continuous improvement and implement processes to enhance regulatory efficiency.

• Utilize previous project insights to refine global regulatory submissions and strategies.

• Encourage innovation and strategic thinking in regulatory planning and execution.

• Carry out other duties and responsibilities as assigned.

⛳️ Requirements

• Bachelor’s or Master’s degree in a scientific field.

• At least 12 years of experience in pharmaceutical Regulatory Affairs.

• In-depth knowledge and experience in interpreting regulations, guidelines, and precedents related to oncology drug development in the US and EU.

• Proven success in preparing and submitting INDs, NDAs, and other significant regulatory filings.

• Experience in engaging with the FDA and other global regulatory bodies.

• Demonstrated capacity to lead and manage several complex projects concurrently.

• Exceptional written, verbal, and interpersonal communication abilities.

• Preferred experience in oncology drug development within a small-to-midsize biotechnology firm.

• Strong leadership and mentoring capabilities with a collaborative approach preferred.

• Ability to excel in a dynamic, cross-functional environment preferred.

• Detail-oriented, proactive, and results-driven mindset preferred.

🏝️ Benefits

• Competitive salary and annual bonus.

• Comprehensive benefits package that includes medical, dental, and vision insurance, as well as a 401(k) retirement plan with company matching, among other perks.

• Generous parental leave and family planning benefits.

• Exceptional company culture and opportunities for both personal and professional development.

• Long-term incentive plan.

• Additional incentive compensation plans (if applicable).