New · posted Oct 31
Spyre Therapeutics · Biotechnology
Director, Regulatory Affairs
- Remote, US
- Remote
- Full-time
- Director
The role
- 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.
Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, IL-23, and IL-17A/F as well as rational combination programs.
What you need
Ideal Candidatenice to have
- 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 you'll do
- 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.
Pay and benefits
$220,000 – $245,000 a year
Employer providedThe 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.
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.
Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email.
Please also be aware that all job postings will be listed on our website at spyre.com/careers/.
Equal opportunity, accessibility and legal noticesSpyre Therapeutics's statements, word for word
As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients.
Job intelligence
The context around this role
Live data · October 31, 2026
Salary intelligence
How the pay compares
This role's midpoint is 1% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Director roles in the US95 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $220,000 | — | $245,000 |
| All US (middle half) | $206,750 | $235,000 | $264,000 |
This role: Spyre Therapeutics's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 31, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 303 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Spyre's own promotion track.
Career resources on Regulatory Affairs
Skills DNA
What this role leans on
How many of the posting's 21 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions6
- Clinical trial conduct6
- Collaboration and leadership6
- GMP and compliance3
- Documentation and SOPs3
- Investigations and CAPA3
- Quality systems and risk1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Spyre on Regulatory Jobs
- 4
- Open roles
- 4
- Distinct roles
- 1
- Locations
By discipline
- Clinical3 75%
- Regulatory1 25%
By level
- Director4 100%
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Director, Regulatory Affairs at Spyre
Open until filled. $220K–$245K a year, employer provided.