Job ID: 7642
Job Title: Director, Regulatory Affairs
Location: Greater Boston, MA
Location: Remote
I’m currently partnering with a well-funded, clinical-stage biopharmaceutical company that is redefining what’s possible in the treatment of cancer and autoimmune diseases. This is a unique opportunity to join a mission-driven organization with a robust and diverse pipeline that targets key drivers of disease and harnesses the power of the immune system.
Position: The Director of Regulatory Affairs will lead the development and execution of comprehensive regulatory strategies across my client’s development programs. This role will ensure alignment with corporate objectives while closely collaborating with cross-functional stakeholders and shaping regulatory strategy across a diverse and evolving product portfolio.
Responsibilities:
- Global regulatory lead, responsible for providing strategic and operational regulatory guidance to development teams, global submission plans, US/EU or other national clinical trial requirements, and health authority interaction leadership.
- Primary point of contact for regulatory authorities and/or contracted regulatory representatives (e.g., CRO local representative).
- Proactively communicate potential regulatory issues and mitigation strategies by facilitating and/or contributing to risk assessments and managing critical issues.
- Analyze international (ICH) and country-specific guidelines, national regulations, and clinical trial/marketing application procedures, and translate complex scientific/technical information into concise written documents and presentations.
- Lead high-quality, on-time regulatory submission execution (IND/CTA/NDA/MAA, as applicable) in compliance with applicable regulatory requirements in a fast-paced matrixed environment and alignment with corporate goals.
- Actively lead or participate in regulatory department infrastructure and capability building, including best practices, templates, training tools, and cross-program knowledge sharing.
- Support due diligence and strategic partnering activities as needed.
- Provide mentorship and coaching to regulatory colleagues to foster a supportive and growth-minded culture.
Requirements:
- BA/BS degree in biological/physical sciences required. Advanced degrees preferred.
- 10+ years of relevant Regulatory Affairs experience in the biotechnology or pharmaceutical industry or a combination of education and experience.
- Direct experience in leading the drug development process, pharmaceutical industry, health authority regulations, healthcare environment, and policies.
- Highly skilled in developing and managing multinational IND and clinical trial applications throughout the product development lifecycle, with a proven track record of significant regulatory accomplishments.
- Experience in autoimmune disease and/or hematology/oncology development
- Demonstrated success in leading teams in the preparation of health authority applications and health authority interactions.
- Independently providing regulatory leadership and guidance on cross-functional teams and working in a matrixed environment.
- Well-versed in evaluating complex scientific information and regulatory guidelines, with a demonstrated ability to formulate recommendations based on assessment.
- Effective communication skills with a demonstrated ability to influence decision-making and/or deliver comprehensive recommendations in written or verbal presentation format.
- Possess strong scientific and business acumen, capable of strategic thinking, planning, and proposing innovative solutions to regulatory challenges.
- Experience with document management and Regulatory Information Management (RIM). Veeva Vault preferred experience.
- Proficient with MS Office tools to perform project management, tracking, writing, and presentation tasks.
