Senior Manager, Regulatory Affairs US & Canada Strategy Lead, Therapeutic Neuroscience - Hybrid
$124,500–$236,500 year
HybridFlorham Park, New Jersey, 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. Identify data needs to support filings and registration maintenance while advising internal customers on regulatory and FDA issues. Independently negotiate project decisions and lead the preparation and review of regulatory submissions consistent with government guidelines. Present pertinent regulatory information to cross-functional areas and implement changes based on accurate interpretation of regulations and corporate policies. Operate in compliance with regulations and the Quality Dossier Program. Requires advanced degree or certification with minimum five years of regulatory 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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