Role OverviewThe Regulatory Affairs Manager supports the development and execution of regulatory strategies to enable the successful development of biological products. 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. The Manager ensures regulatory requirements are understood and incorporated into program activities while maintaining compliance with global regulations and internal standards. The Regulatory Manager will have recognition as a leading role in their assigned programs, and will work with support and guidance from senior regulatory management as needed.
Key Responsibilities - 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.
- 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.
Qualifications - Bachelor's degree from an accredited institution 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.
- 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.
- Familiarity with ex-US regulatory requirements preferred.
- 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.
Position Location This is a remote role; periodic travel to team and company events is required.
The anticipated salary range for candidates for this role is
$135,000 - $150,000 The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography.
