Jade Biosciences
Manager, Regulatory Affairs
Boston; Remote; San Francisco; Seattle
Sponsorship not specified$135k-$150kDetected 25 days ago
GCPComplianceExcelGMPFDA RegulatoryAnimal StudiesCommunicationOrganizational SkillsRegulatory Affairs
About the role
- This role is responsible for coordinating, compiling, and reviewing initial health authority submissions, as well as the preparation of timely, high-quality responses to health authority questions.
Responsibilities
- Draft, edit, and review regulatory documents such as meeting requests, query responses, and submission modules.
- Participate in the review of key clinical and nonclinical documents (protocols, IBs, CSRs, DSURs, etc.) to ensure alignment with regulatory obligations and relevant guidelines (ICH, FDA, EMA, ROW).
- Manage the processing, formatting, and operational aspects of regulatory submissions, ensuring compliance with regulatory requirements and internal quality standards.
- Maintain up‑to‑date knowledge of US and global regulations, guidance documents, and evolving regulatory expectations.
- Support continuous improvement initiatives to enhance regulatory compliance, efficiency, and documentation quality
- The Regulatory Manager will have recognition as a lead ing role in their assigned programs, and will work with support and guidance from senior regulatory management as needed.
Requirements
- Bachelor's degree from an accredited institution required.
- Strong ability to interpret scientific data and understand regulatory implications for biologics.
- experience with eCTD submissions required.
- Excellent written and verbal communication skills, including the ability to clearly articulate regulatory positions.
- Ability to work independently and collaboratively within a matrixed, multidisciplinary environment.
- High proficiency in MS Word, Excel, Adobe Acrobat, and regulatory document management systems.
- periodic travel to team and company events is required.
- Drives timely submission of regulatory submissions including initial trial applications (e.g. IND, CTA) and marketing applications, and the documentation required to maintain these applications.
- Direct experience supporting US regulatory submissions, including IND preparation or maintenance; experience with eCTD submissions required.
- 5-8+ years of pharmaceutical/biotech R&D experience, including 3-5+ years in Regulatory Affairs (or equivalent combination of education and experience). Small-midsize biotech experience highly preferred.
- Direct experience supporting US regulatory submissions, including IND preparation or maintenance
- Experience contributing to or coordinating health authority submissions and responses.
- Solid understanding of US and global regulations and guidelines (21 CFR, FDA, ICH, GCP, GMP, eCTD).
- Demonstrated ability to identify regulatory risks and support resolution strategies.
- Strong organizational skills with the ability to manage multiple priorities and meet deadlines.
- Position Location
Nice to have
- Small-midsize biotech experience highly preferred.
- Familiarity with ex ‑ US regulatory requirements preferred.
Compensation
- The anticipated salary range for candidates for this role is $135,000 - $150,000.
Benefits
- Identify regulatory risks proactively and contribute to risk‑benefit assessments and mitigation strategies.
- 5-8+ years of pharmaceutical/biotech R&D experience, including 3-5+ years in Regulatory Affairs (or equivalent combination of education and experience).
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This listing is sourced directly from Jade Biosciences's careers page and normalized into a canonical job model.