Position Overview:
SAB BIO is seeking a Regulatory Affairs Associate who will support regulatory activities with a focus on CMC (Chemistry, Manufacturing, and Controls) for current and future programs. Reporting to the Senior Manager, Regulatory Affairs, this remote, U.S.-based role helps ensure compliance with FDA and global regulations, supports regulatory submissions, and collaborates cross-functionally to maintain alignment with company and quality goals.
Key Responsibilities:
- Support and manage regulatory aspects of existing and new programs.
- Analyze FDA submission requirements and review agency requests.
- Assist in preparing CMC components of submissions (INDs, amendments, supplements, annual reports).
- Review regulatory documents (INDs, CTAs, Briefing Books), identifying gaps.
- Maintain regulatory databases and track submission progress.
- Act as liaison with regulatory agencies during audits and inspections.
- Collaborate with cross-functional teams (R&D, QA/QC, Manufacturing) to support compliance.
- Document regulatory communications and ensure accurate reporting.
- Contribute to risk management strategies related to product quality and compliance.
Qualifications:
- Bachelor’s degree in a scientific field.
- 2+ years of CMC experience in regulatory affairs.
- Familiarity with FDA, EMA, MHRA, TGA regulations and guidance.
- Understanding of pharmaceutical product development and lifecycle management.
- Experience with eCTD publishing, regulatory submissions, and regulatory databases.
- Strong communication, attention to detail, and cross-functional collaboration skills.
- Proficiency with Microsoft Excel, Word, PowerPoint.
Job sourced from SAB BIO.