Regulatory Affairs Manager - Albion Rye Associates

About Us

My client is an emerging clinical-stage biotechnology company with a robust pipeline of innovative therapies designed to address significant unmet medical needs. The team is driven by a passion for science, a commitment to excellence, and a culture that values collaboration and innovation. As we expand our development programs, they are seeking a Regulatory Affairs Manager to join our dynamic team.

Position Summary

The Regulatory Affairs Manager will be a key contributor in navigating the complex regulatory landscape, ensuring compliance, and facilitating the timely development and approval of our pipeline products. This role requires hands-on involvement in regulatory strategies and submissions, working closely with cross-functional teams to drive global regulatory activities for clinical and pre-commercial products.

Key Responsibilities

• Develop and implement regulatory strategies to support clinical development and product registration objectives.
• Ensure alignment with corporate goals, regulatory requirements, and emerging regulatory trends.
• Lead the preparation, review, and submission of regulatory dossiers, including INDs/CTAs, amendments, annual reports, and responses to health authority inquiries.
• Manage global regulatory submissions, ensuring compliance with FDA, EMA, and other regulatory agencies’ guidelines.
• Serve as a point of contact for regulatory agencies, coordinating and leading meetings, responses, and communications.
• Prepare teams for agency meetings and lead the development of briefing packages and related materials.
• Partner with clinical, preclinical, quality, and CMC teams to ensure regulatory requirements are integrated into development plans.
• Provide regulatory guidance throughout the lifecycle of the products in the pipeline.
• Monitor and interpret regulatory trends and guidance documents, advising teams on potential impact to development programs.
• Maintain an up-to-date understanding of global regulatory requirements.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, or a related field. Advanced degree (e.g., MS, PharmD, PhD) preferred.
• Minimum of 5-7 years of regulatory affairs experience in the biotech or pharmaceutical industry.
• Proven track record in preparing and managing regulatory submissions (INDs, CTAs, etc.) and interfacing with regulatory agencies.
• Experience with products in clinical development stages is required.
• Strong understanding of global regulatory requirements, including FDA, EMA, and ICH guidelines.
• Excellent project management, organizational, and problem-solving skills.
• Strong communication and interpersonal skills with a demonstrated ability to work effectively in a cross-functional team environment.