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.

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.

Manager, Regulatory Affairs

Key skills