Manager, Regulatory Affairs

Jade Biosciences

Manager of Regulatory Affairs in clinical-stage biotech specializing in therapies for autoimmune diseases. Supports regulatory strategies and submissions for biological products.

Posted 6/26/2026full-timeRemote • California, Massachusetts, Washington • 🇺🇸 United StatesMid-LevelSenior💰 $135,000 - $150,000 per yearWebsite

ATS Keywords

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Hard Skills

regulatory submissionsIND preparationeCTD submissionsregulatory reviewscientific data interpretationrisk identificationregulatory complianceclinical study planningbiologics regulationsGCP

Soft Skills

organizational skillscommunication skillscollaborationindependenceability to manage multiple prioritiesattention to detailproblem-solvingtime managementadaptabilitystakeholder communication

Tools & Technologies

MS WordExcelAdobe Acrobatregulatory document management systems

Industry Keywords

pharmaceuticalbiotechRegulatory Affairs21 CFRFDAICHGMPclinical documentssubmission modulesrisk-benefit assessments

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Drives timely submission of regulatory submissions including initial trial applications (e.g. IND, CTA) and marketing applications.
Draft, edit, and review regulatory documents such as meeting requests, query responses, and submission modules.
Conduct regulatory review of product documentation intended for submissions to ensure accuracy, consistency, and compliance with FDA and global regulations.
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.
Identify regulatory risks proactively and contribute to risk-benefit assessments and mitigation strategies.
Maintain up-to-date knowledge of US and global regulations, guidance documents, and evolving regulatory expectations.
Monitor the external regulatory landscape and communicate potential impacts to internal stakeholders.
Support continuous improvement initiatives to enhance regulatory compliance, efficiency, and documentation quality.
Provide regulatory input into clinical study planning and execution, including identification of regulatory requirements and expectations, as a member of operational study teams.

Requirements

What you’ll need

Bachelor’s degree from an accredited institution required.
5–8+ years of pharmaceutical/biotech R&D experience, including 3–5+ years in Regulatory Affairs.
Strong ability to interpret scientific data and understand regulatory implications for biologics.
Direct experience supporting US regulatory submissions, including IND preparation or maintenance; experience with eCTD submissions required.
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.
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.

Benefits

Comp & perks

Health insurance
Paid time off
Professional development opportunities