Director, Regulatory Affairs

The role

The Director, Regulatory Affairs will manage and oversee regulatory affairs activities, initially focused on the IBD program. This person will plan and execute regulatory strategies to enable clinical trials and contribute to development plans for product approval.

What you will do

• Develop and implement regulatory strategies for clinical trials and marketing applications.
• Prepare, review, and submit regulatory applications and dossiers to global health authorities.
• Plan meeting strategy, lead development of briefing materials, and support health authority meetings.
• Represent the company in regulatory interactions and respond to inquiries.
• Communicate regulatory agency interactions to leadership and cross-functional teams.
• Identify potential regulatory risks and develop mitigation strategies.
• Monitor changes in regulatory landscapes and assess impact on products.
• Keep abreast of new regulations, guidelines, and best practices.
• Collaborate with Pre-clinical R&D, Clinical Development, Technical Operations, Legal, and Quality and Compliance.
• Contribute to development and management of the regulatory affairs budget.

Required qualifications

• Bachelor’s degree with 8-10 years of experience in pharmaceutical regulatory affairs and/or related disciplines, or an equivalent combination of relevant education, training, and experience.
• Proven track record of successfully managing complex regulatory submissions.
• Proven experience managing clinical trial applications in the US and globally.
• Strong knowledge of global pharmaceutical regulations and guidelines, including FDA, EMA, and ICH requirements.
• Proficient in medical and/or technical writing, including authoring Module 2 and 3 summaries, DSURs, safety reports, investigational brochures, clinical trial protocols, clinical trial reports, and/or
• Excellent leadership, communication, and interpersonal skills.
• Strong problem-solving and critical thinking abilities.
• Ability to meet deadlines and adapt to changing priorities.
• Proficiency in regulatory affairs software and document management systems.

Nice to have

• Experience with CMC regulatory, device (e.g., pre-filled syringe and/or auto-injector) and/or diagnostic (e.g., companion diagnostics)

Benefits

• Market competitive compensation and benefits package
• Base salary
• Performance bonus
• Equity grant opportunities
• Health, welfare & retirement benefits
• Unlimited PTO
• Two, one-week company-wide shutdowns each
• Professional development opportunities

About the company

Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies in immunology. Their pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, IL-23, and IL-17A/F.