Director, Regulatory Affairs

Spyre Therapeutics

1d•$220,000 - $245,000•Remote

About The Position

Spyre Therapeutics is a clinical-stage biotechnology company developing next-generation immunology therapies, including extended half-life antibodies targeting α4β7, TL1A, IL-23, and IL-17A/F, as well as rational combination programs. The Director, Regulatory Affairs will manage and oversee regulatory affairs activities, initially focused on Spyre’s IBD program. This role plans and executes regulatory strategies to enable clinical trials and contributes to preclinical, CMC, and clinical development plans to support studies needed for product approvals consistent with target product profiles. The Director serves as the overall lead for global regulatory applications for one or more drug candidates, leads original investigational new drug and clinical trial applications, and plans and prepares for meetings with global health authorities, including FDA Type C and EOP2 meetings and EMA scientific advice meetings. The role also supports development of other assets and helps establish Regulatory Department processes. The position collaborates across Pre-clinical Research & Development, Clinical Development, Technical Operations, Legal, and Quality and Compliance. Spyre offers a remote working environment with frequent in-person meetings. The expected salary range is $220,000 to $245,000; actual pay may vary based on job-related knowledge, experience, education, and geographic location.

Requirements

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 managing complex regulatory submissions.
Experience managing clinical trial applications in the United States and globally.
Strong knowledge of global pharmaceutical regulations and guidelines, including FDA, EMA, and ICH requirements.
Proficiency in medical and/or technical writing, including authoring or contributing 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.

Nice To Haves

Experience with CMC regulatory matters.
Experience with devices, such as pre-filled syringes and/or auto-injectors.
Experience with diagnostics, such as companion diagnostics.

Responsibilities

Develop and implement regulatory strategies that enable clinical trials and marketing applications.
Monitor evolving regulatory requirements and industry trends, and advise the company on regulatory expectations.
Prepare, review, and submit regulatory applications and dossiers to agencies including the FDA, EMA, PMDA, and other global regulatory agencies.
Plan health authority meeting strategies, lead preparation of briefing materials, capture action items, and support implementation of meeting outcomes and strategy.
Represent the company in regulatory interactions; maintain communication with regulatory agencies and respond to inquiries and requests.
Communicate agency interactions and guidance to Regulatory Affairs leadership and cross-functional teams.
Identify regulatory risks and develop mitigation strategies; monitor regulatory landscape changes and assess their impact on company products.
Keep abreast of regulations, guidelines, and industry best practices and adapt company strategies accordingly.
Collaborate with Pre-clinical Research & Development, Clinical Development, Technical Operations, Legal, and Quality and Compliance to integrate regulatory considerations into product development.
Contribute to development and management of regulatory affairs budgets for assigned projects.
Lead global regulatory applications for one or more drug candidates, including original investigational new drug and clinical trial applications.
Contribute to development of other assets and to processes for the Regulatory Department.