Manager, Regulatory Affairs

This is a fully remote position, open to applicants in California, +2 more states.

📋 Description

• Ensures timely submission of regulatory filings, including initial trial applications (e.g., IND, CTA) and marketing applications.

• Prepare, revise, and assess regulatory documents such as meeting requests, responses to queries, and submission modules.

• Perform regulatory reviews of product documentation intended for submissions to guarantee accuracy, consistency, and adherence to FDA and global regulations.

• Engage in the evaluation of critical clinical and nonclinical documents (protocols, IBs, CSRs, DSURs, etc.) to ensure compliance with regulatory obligations and pertinent guidelines (ICH, FDA, EMA, ROW).

• Oversee the processing, formatting, and operational components of regulatory submissions, ensuring conformity with regulatory standards and internal quality benchmarks.

• Proactively identify regulatory risks and contribute to risk-benefit assessments and mitigation strategies.

• Stay informed about US and global regulations, guidance documents, and the evolving landscape of regulatory expectations.

• Track the external regulatory environment and relay potential impacts to internal stakeholders.

• Assist in continuous improvement efforts to enhance regulatory compliance, operational efficiency, and the quality of documentation.

• Provide regulatory insights into clinical study planning and execution, including the identification of regulatory requirements and expectations as part of operational study teams.

⛳️ Requirements

• A Bachelor’s degree from an accredited institution is required.

• 5–8+ years of experience in pharmaceutical/biotech R&D, with 3–5+ years specifically in Regulatory Affairs.

• Strong capability to interpret scientific data and comprehend regulatory implications for biologics.

• Direct experience in supporting US regulatory submissions, including IND preparation or maintenance; experience with eCTD submissions is required.

• Experience in contributing to or coordinating submissions and responses to health authorities.

• Solid understanding of US and global regulations and guidelines (21 CFR, FDA, ICH, GCP, GMP, eCTD).

• Proven ability to identify regulatory risks and aid in developing resolution strategies.

• Strong organizational skills with the capacity to manage multiple priorities and adhere to deadlines.

• Excellent written and verbal communication skills, with the ability to clearly express regulatory positions.

• Capability to work both independently and collaboratively within a matrixed, multidisciplinary environment.

• High proficiency in MS Word, Excel, Adobe Acrobat, and regulatory document management systems.

🏝️ Benefits

• Health insurance

• Paid time off

• Professional development opportunities