Head of Regulatory Affairs - Lowell

About Us:

We are an emerging biotechnology company dedicated to advancing breakthrough therapies in oncology. With a pipeline of innovative candidates aimed at transforming patient outcomes, we are committed to addressing unmet medical needs through cutting-edge science and collaboration.

Position Overview:

The Head of Regulatory Affairs will serve as a strategic leader, responsible for developing and executing regulatory strategies to support the clinical development, approval, and commercialization of our oncology therapies. Reporting directly to the CEO/CSO (as applicable), this role will play a critical part in navigating the regulatory landscape, building relationships with health authorities, and ensuring compliance with global regulatory requirements.

Key Responsibilities:

• Develop and implement comprehensive global regulatory strategies for the company’s oncology pipeline.
• Provide strategic input to cross-functional teams, including clinical, research, and commercial, to ensure alignment with regulatory requirements.
• Oversee the preparation, submission, and maintenance of regulatory filings, including INDs, NDAs, MAAs, and orphan drug applications.
• Lead interactions with regulatory agencies (FDA, EMA, etc.) to facilitate approvals and provide guidance on regulatory expectations.
• Ensure compliance with all applicable regulatory standards and guidelines (e.g., ICH, FDA, EMA, and other regional requirements).
• Monitor regulatory changes and trends in oncology to proactively adjust strategies as needed.
• Build, mentor, and lead a high-performing regulatory affairs team.
• Collaborate with internal stakeholders and external partners to drive regulatory excellence and ensure alignment with corporate objectives.
• Assess regulatory risks and develop mitigation strategies to support efficient decision-making.
• Provide expertise in regulatory pathways, expedited programs (e.g., Fast Track, Breakthrough Therapy), and innovative approaches to accelerate development timelines.

Qualifications:

• Advanced degree in life sciences (e.g., PharmD, PhD, MD) or a related field.
• A minimum of [10+] years of regulatory affairs experience in the biotechnology or pharmaceutical industry, with a focus on oncology preferred.
• Proven track record of successful regulatory filings and approvals, including interactions with major health authorities.
• Strong understanding of the global regulatory environment, particularly in oncology drug development.
• Exceptional leadership, communication, and organizational skills.
• Ability to work in a fast-paced, dynamic environment and manage multiple priorities effectively.
• Entrepreneurial mindset with a collaborative approach to problem-solving.