This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Manager, Regulatory Affairs Strategy based in the United States.
This role sits within a global regulatory organization focused on advancing late-stage development programs for innovative therapies in rare diseases. The Manager will play a key role in shaping and executing global regulatory strategies from clinical development through registration and lifecycle management. Working in a highly collaborative, matrixed environment, this position partners closely with cross-functional teams including clinical, nonclinical, CMC, and regulatory operations. The role is central to preparing and delivering high-quality regulatory submissions and ensuring alignment with evolving global requirements. It also involves active participation in health authority interactions and major regulatory milestones such as marketing applications. This is a high-impact opportunity to contribute directly to programs that aim to bring life-changing treatments to patients with serious unmet needs.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Manager, Regulatory Affairs Strategy based in the United States.
This role sits within a global regulatory organization focused on advancing late-stage development programs for innovative therapies in rare diseases. The Manager will play a key role in shaping and executing global regulatory strategies from clinical development through registration and lifecycle management. Working in a highly collaborative, matrixed environment, this position partners closely with cross-functional teams including clinical, nonclinical, CMC, and regulatory operations. The role is central to preparing and delivering high-quality regulatory submissions and ensuring alignment with evolving global requirements. It also involves active participation in health authority interactions and major regulatory milestones such as marketing applications. This is a high-impact opportunity to contribute directly to programs that aim to bring life-changing treatments to patients with serious unmet needs.
Accountabilities:
- Provide regulatory leadership and execution support for late-stage development and registration programs, contributing to global regulatory strategy implementation.
- Serve as a core Regulatory Affairs representative on cross-functional teams, ensuring regulatory considerations are integrated across development, submission, and lifecycle activities.
- Coordinate and support preparation of regulatory submissions including INDs, CTAs, amendments, annual reports, briefing packages, and marketing applications (NDA, BLA, MAA components).
- Lead or contribute to the development of regulatory documents and ensure dossier readiness in collaboration with internal subject matter experts.
- Support Health Authority interactions, including meeting requests, briefing materials, responses to agency questions, and post-meeting commitments.
- Drive submission planning, timeline management, and tracking of key regulatory deliverables to ensure timely execution.
- Identify regulatory risks and support mitigation strategies while contributing to process improvements and regulatory best practices.
- Manage external regulatory consultants and vendors as needed, while supporting lifecycle management activities including post-approval changes and labeling updates.
- Bachelor’s degree in Life Sciences or a related field required; advanced degree (MS, PharmD, PhD, or equivalent) preferred.
- 6+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Strong experience supporting clinical-stage and late-stage development programs, including Phase 3 and global regulatory submissions.
- Working knowledge of FDA, EMA, ICH, and other global regulatory frameworks and requirements.
- Hands-on experience supporting IND, CTA, and related regulatory submissions.
- Experience contributing to registration planning, dossier development, lifecycle management, and post-approval regulatory activities.
- Strong project management, organizational, and multitasking skills in a fast-paced environment.
- Excellent written and verbal communication skills with strong cross-functional collaboration ability.
- Demonstrated problem-solving skills, sound regulatory judgment, and ability to work independently.
- Experience participating in Health Authority interactions and managing global regulatory expectations is highly preferred.
- Competitive base salary range: $116,000 – $151,000.
- Short-term incentive bonus and long-term equity (stock) compensation opportunities.
- Comprehensive health coverage including medical, dental, and vision plans.
- Retirement plan with employer matching contributions.
- Life insurance and disability coverage.
- Generous paid time off and work-life balance support programs.
- Employee wellness initiatives and support resources.
- Flexible benefits supporting financial, physical, and mental well-being.