Role Summary:- As the Director, Regulatory Affairs, you will play a key role in managing and overseeing regulatory affairs activities and execution within our organization, initially focused on Spyre's IBD program. You will be responsible for planning and executing regulatory strategies that enable Spyre to initiate and manage clinical trials. You will also contribute to preclinical, CMC, and clinical development plans with the goal of ensuring Spyre performs the necessary studies to gain and maintain product approval(s) that are consistent with our target product profile(s).
- You will act as the overall lead of global regulatory applications for one or more drug candidates and will lead the submission of original investigational new drug and clinical trial applications. You will lead efforts to plan and prepare for meetings with global health authorities (Type C & EOP2 meetings with FDA, EMA scientific advice, etc.) and support live discussions. You will also support the team by contributing to the development of other assets for which you are not the overall lead, and by contributing to the development of processes for the Regulatory Department.
Key Responsibilities: - Regulatory Strategy: Develop and implement regulatory strategies that enable the company's clinical trials and marketing applications. Stay current with evolving regulatory requirements and industry trends and advise the company on regulatory expectations.
- Regulatory Submissions: Prepare, review, and submit regulatory applications and dossiers to health authorities, such as the FDA, EMA, PMDA, and other global regulatory agencies, ensuring timely and successful approvals.
- Health Authority Meetings: Plan meeting strategy, lead the development of briefing materials, capture action items, and support the team in implementation and strategy.
- Communication: Represent the company in regulatory interactions and maintain effective communication with regulatory agencies, responding to inquiries and requests in a professional and efficient manner. Communicate regulatory agency interactions and guidance to Regulatory Affairs leadership and cross-functional teams.
- Risk Management: Identify potential regulatory risks and proactively develop strategies to mitigate them. Monitor changes in regulatory landscapes and assess their impact on the company's products.
- Regulatory Intelligence: Keep abreast of new and evolving regulations, guidelines, and best practices in the pharmaceutical industry and adapt company strategies accordingly.
- Cross-functional Collaboration: Collaborate with other departments, including Pre-clinical Research & Development, Clinical Development, Technical Operations, Legal, and Quality and Compliance to ensure regulatory considerations are integrated into the product development process.
- Budget Management: Contribute to development and management of the regulatory affairs budget for assigned projects, ensuring cost-effective use of resources while maintaining high-quality regulatory activities.
Ideal Candidate: - 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 the ability to author or contribute to documents such as Module 2 and 3 summaries, DSURs, safety reports, investigational brochures, clinical trial protocols, clinical trial reports, and/or IMPDs
- 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.
- Experience with CMC regulatory, device (e.g., pre-filled syringe and/or auto-injector) and/or diagnostic (e.g., companion diagnostics)
What We Offer:- Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
- Unlimited PTO
- Two, one-week company-wide shutdowns each
- Commitment to provide professional development opportunities.
- Remote working environment with frequent in-person meetings to address complex problems and build relationships.
The expected salary range offer for this role is $220,000 to $245,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.
