Senior Manager, Regulatory Affairs US & Canada Strategy Lead, Therapeutic Neuroscience - Hybrid
$124,500–$236,500 year
HybridNorth Chicago, Illinois, United States
Job Summary
Develop and execute US and Canada regulatory strategic and tactical planning for assigned on-market and development products. Serve as the Health Authority liaison, coordinating FDA meetings, briefing packages, and responses to inquiries. Advise internal customers on regulatory and FDA issues across Public Affairs, Clinical Development, Legal, and Commercial functions. Independently negotiate project decisions and prepare regulatory submissions consistent with government guidelines, ensuring timely responses during application reviews. Recommend changes to difficult projects based on accurate interpretation of regulations and corporate policies. Present pertinent regulatory information to cross-functional areas while maintaining compliance with company procedures. Operate in a complex matrix environment with significant sitting time, requiring advanced degrees and minimum five years of regulatory industry experience.
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
- Excellent negotiation skills
- Problem solving skills
- Consensus building
- 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
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