Associate Director, Regulatory Affairs
Recursion
In this role, you will:
- Build intra- and inter-team relationships and collaborate globally to manage regulatory strategy and activities across applicable jurisdictions (EU, US, UK) throughout development and post-approval.
- Participate in global product team meetings; provide regulatory support and guidance; manage day-to-day regulatory activities.
- Manage complex issues and coordinate multiple time-sensitive projects; perform risk assessment (immediate and long-term impacts).
- Create and follow procedures for regulatory execution and implement regulatory strategies; support program leads via Clinical Study Teams (CSTs) to deliver objectives (e.g., clinical trial applications, marketing authorization applications, orphan drug designation, pediatric submissions).
- Comply with disclosure and transparency policies for applicable jurisdictions.
- Collaborate with Strategic Operations and other functions (Clinical, Commercial, Medical Affairs) to provide regional regulatory insight for planning.
- Serve as point of contact with Health Authorities and/or lead interactions with external stakeholders.
- Review and interpret regulatory guidelines; develop communication plans to share impact; influence regulatory science through innovative technology use/validation.
- Stay current on regulations and guidance; attend relevant meetings; read scientific literature; represent the regulatory function with ethics and transparency.
The experience youβll need:
- 10+ years in pharma, including 8+ years in Global Regulatory Affairs; experience with major Health Authorities (US FDA, Health Canada, UK MHRA, EMA) (required). Oncology, rare disease, and I&I are a plus.
- 8+ years with regulatory submissions (INDs, NDA/NDS/MAA, post-marketing measures, Paediatric Investigation Plans (PIP)/(PSP), Orphan Drug Designation (ODD), Breakthrough Designation (BTD), EU PRIME) (required).
- Strong regulatory strategy and operational implementation understanding; exceptional management, interpersonal, communication, negotiation, and problem-solving skills; proven cross-functional global teamwork.
Working location:
- Remote-friendly; occasional travel to Salt Lake City headquarters/other locations.
Compensation (base salary range):
- NYC/Boston/San Francisco Bay Area: $194,040β$228,250
- Salt Lake City & all other U.S. locations: $176,400β$207,500
- Eligible for annual bonus, equity compensation, and comprehensive benefits package.