Senior Manager, Regulatory Affairs US & Canada Strategy Lead, Therapeutic Neuroscience - Hybrid
$124,500–$236,500 year
HybridCambridge, Massachusetts, United States
Job Summary
Develop and execute US and Canada regulatory strategic and tactical planning for assigned on-market and development products. Serve as Health Authority liaison, coordinating FDA meetings, briefing packages, and responses to inquiries. Advise internal customers on Regulatory/FDA issues across Public Affairs, Clinical Development, Legal, and Commercial. Independently negotiate project decisions and prepare regulatory submissions consistent with government requirements and the Quality Dossier Program. Present pertinent regulatory information to cross-functional areas while operating in compliance with company policies. This role requires continuous sitting for prolonged periods and supports the Global Regulatory Lead in managing moderate-impact business activities. Candidates must possess advanced degrees or certifications with at least five years of regulatory experience, including interfacing with government agencies and implementing affiliate regulatory strategies.
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
- Experience interfacing with government regulatory agencies
- Proven skill at implementing successful affiliate regulatory strategies (US or Canada experience preferred)
Desired Qualifications
- Advanced Degree and/or Certifications or direct experience with pharmaceutical regulatory activities
- Global regulatory experience
- Experience working in a complex and matrix environment
- 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. Able to deliver challenging messages effectively without compromising important business relationships
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.