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) to post-marketing phases.

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

• Observe and analyze global regulatory trends, communicating potential impacts on programs to senior leadership.

• Oversee the preparation and submission of INDs, NDAs, and other regulatory documents.

• Ensure that submissions are of high quality, compliant, and fulfill global regulatory standards.

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

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

• Offer regulatory guidance to project teams and senior management.

• Represent Regulatory Affairs in internal and external meetings, including discussions with regulatory authorities.

• 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 Regulatory Affairs.

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

• Utilize previous project experiences to optimize global regulatory submissions and strategies.

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

• Carry out additional 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.

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

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

• Experience interacting with the FDA and other global regulatory agencies.

• Capability to lead and manage multiple complex projects concurrently.

• Exceptional written, verbal, and interpersonal communication skills.

• Strategic mindset with the ability to foresee regulatory challenges and propose creative solutions.

• Experience in oncology drug development within a small-to-midsize biotechnology company.

• Strong leadership and mentoring abilities with a collaborative approach.

• Ability to excel in a fast-paced, cross-functional setting.

• Detail-oriented, proactive, and results-focused attitude.

🏝️ Benefits

• Competitive salary along with an annual bonus.

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

• Generous parental leave policies and family planning benefits.

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

• Long-term incentive plan.

• Additional incentive compensation plans (if applicable).