Director, Global Regulatory Strategy & Submissions

Spyre Therapeutics, Inc.; United States; Hybrid; USD 220,000 - 245,000; Full time

Benefits offered by this job

Equity grant opportunities

Health, welfare & retirement benefits

Unlimited PTO

Two one-week shutdowns

Professional development opportunities

Remote work with in-person meetings

Job summary

Spyre Therapeutics, Inc. is seeking a Director of Regulatory Affairs to oversee global regulatory programs for its IBD portfolio and other drug candidates. You will drive regulatory strategy, leading FDA/EMA submissions, and planning interactions with health authorities.

The role requires strong leadership, medical writing, and cross-functional collaboration to ensure timely approvals while managing regulatory risk and budgets. A hybrid work model and competitive compensation are offered.

Qualifications

• Bachelor’s degree with 8-10 years of experience in pharmaceutical regulatory affairs.
• Proven track record of managing complex regulatory submissions.
• Experience managing clinical trial applications in the US and globally.
• Strong knowledge of FDA, EMA, and ICH requirements.
• Excellent leadership, communication, and interpersonal skills.
• Proficiency in regulatory affairs software and document management systems.

Responsibilities

• Regulatory Strategy: Develop and implement regulatory strategies that enable the company’s clinical trials and marketing applications.
• Regulatory Submissions: Prepare, review, and submit regulatory applications and dossiers to health authorities, such as the FDA, EMA, PMDA, and other global regulatory agencies.
• 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.
• Risk Management: Identify potential regulatory risks and proactively develop strategies to mitigate them.
• 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 to ensure regulatory considerations are integrated into product development.
• Budget Management: Contribute to development and management of the regulatory affairs budget for assigned projects.

Skills

Regulatory strategy

Regulatory submissions

FDA/EMA/ICH knowledge

Medical writing

Leadership

Communication

Project management

Regulatory software

CMC/Device/Diagnostics experience

Deadline adherence

Education

Bachelor’s degree in related field

Job description

Spyre Therapeutics, Inc. is seeking a Director of Regulatory Affairs to oversee global regulatory programs for its IBD portfolio and other drug candidates. You will drive regulatory strategy, leading FDA/EMA submissions, and planning interactions with health authorities.

The role requires strong leadership, medical writing, and cross-functional collaboration to ensure timely approvals while managing regulatory risk and budgets. A hybrid work model and competitive compensation are offered.