Director, Regulatory Affairs
Benefits
Unlimited PTO
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Role Summary:
- As the Director, Regulatory Affairs, you will manage regulatory activities for Spyre's IBD program.
- You will plan and execute regulatory strategies for clinical trials and marketing applications.
- You will lead global regulatory submissions and interactions with health authorities.
Key Responsibilities:
- Develop and implement regulatory strategies that enable clinical trials and marketing applications.
- Prepare, review, and submit regulatory applications to FDA, EMA, and other global agencies.
- Identify potential regulatory risks and proactively develop strategies to mitigate them.
Ideal Candidate:
- Bachelor's degree with 8-10 years experience in pharmaceutical regulatory affairs.
- Proven track record of managing complex regulatory submissions and CTAs globally.
- Strong knowledge of FDA, EMA, and ICH requirements with excellent communication skills.
Spyre Therapeutics
Spyre Therapeutics is a clinical-stage biotechnology company developing next-generation immunology therapies. It is a young company with a fast-paced, dynamic culture focused on advancing meaningful medicines for patients.