Senior Manager, Regulatory Affairs US & Canada Strategy Lead, Therapeutic Neuroscience - Hybrid
$124,500–$236,500 year
HybridIrvine, California, United States
Job Summary
Develop and implement US and Canada regulatory strategic and tactical planning for assigned on-market and development products. Serve as Health Authority liaison for FDA meetings, coordinate briefing packages, and gather data to support filings and registration maintenance. Advise internal customers on regulatory issues and independently negotiate cross-functional project decisions. Prepare and review regulatory submissions consistent with US and Canada requirements, ensuring timely responses during application review. Recommend project changes based on accurate interpretation of government regulations and corporate policies. Present pertinent regulatory information to cross-functional areas while operating in compliance with the Quality Dossier Program.
Required Qualifications
- Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification
- Minimum 5 years Regulatory, R&D, or equivalent industry-related experience
- Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
- US & Puerto Rico only
Desired Qualifications
- Advanced Degree and/or Certifications or direct experience with pharmaceutical regulatory activities
- Proven skill at implementing successful affiliate regulatory strategies (US or Canada experience preferred)
- Global regulatory experience is a plus
- Demonstrates excellent negotiation skills, problem solving skills and builds consensus
- Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization
- Experience working in a complex and matrix environment
- Experience interfacing with government regulatory agencies
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