Associate Director Regulatory Affairs

Summary of Key Responsibilities:
- Serve as US Regional Lead or Global Regulatory Lead for early/mid/late-stage CNS programs.
- Lead and define regulatory strategy; compile and submit regulatory documents on time and lead US HA interactions (e.g., FDA forms, meeting requests, briefing documents, new INDs, marketing applications, pediatric plans, orphan designation, expedited pathway applications such as Breakthrough Designation).
- Develop detailed regulatory project plans and support regulatory activities for assigned portfolios.
- Serve as a member/lead of the Global Regulatory Team; represent Regulatory on multidisciplinary product subteams/core team and participate actively.
- Coordinate timely responses to regulatory authority questions.
- Liaison with internal departments, CROs, and regulatory program managers at Health Authorities.
- Maintain regulatory files per internal requirements.
- Oversee review of technical regulatory documentation and recommend changes to documentation/processes, including regulatory compliance SOPs.
- Provide EU-specific regulatory intelligence as appropriate.

Qualifications:
- Bachelor’s degree with 6+ years in Regulatory Affairs (minimum 8 years biotech/pharma industry experience).
- Excellent written/verbal communication, negotiation, and influencing skills.
- Solid understanding of regulations and experience interpreting guidelines.
- Strategic thinking; proactively identify issues and mitigation strategies across drug development.
- Experience with US regulatory filings and leading interactions with US FDA.
- Excellent organizational/project management; ability to prioritize multiple projects.
- Teamwork and strong interpersonal skills with internal stakeholders and CROs/consultants.
- Technical system skills (e.g., word processing, spreadsheets, databases, online research) for submission-ready formatting.
- Alignment with core values: Commitment to People; Fiercely Innovative; Purposeful Urgency; Open Culture; Passion for Excellence.