Principal Scientist (Manager), Global Regulatory Affairs, CMC
$117,000–$201,250 year
On-siteRaritan, New Jersey, United States or Horsham, Pennsylvania, United States
Job Summary
Lead global CMC regulatory activities for large molecules across clinical development and post-marketing phases, developing submission plans that comply with local requirements and executing global regulatory strategies. Represent CMC Regulatory Affairs on cross-functional teams to provide regulatory expertise, review dossiers for health authority submissions, and manage interactions with regulators. Drive continuous improvement in compliance standards, develop contingency plans for registration issues, and serve as a single point of contact for internal and external policy influence. This role requires a Principal Scientist with 8+ years of experience in biologics and large molecules, based in Horsham, PA, or nearby NJ locations, with a salary range of $117,000 to $201,250.
Required Qualifications
- A BS/BA in biological, pharmaceutical, chemical or engineering sciences
- Minimum of 8+ years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent
- Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry
- Experience in biologics
- Experience in product development/LCM of the large molecules
- The ability to potentially travel up to 10% travel, domestic and/or international
Desired Qualifications
- An MS, Ph.D., or Pharm. D. degree
- Experience developing regulatory strategies
- An understanding of product development
- Knowledge of EU and FDA regulations
- Demonstrates model behavior that understands what the priorities are and encourages others to drive for results
- High-level verbal and written communication skills
- Strong attention to detail
- Benchmarking
- Coaching
- Consulting
- Corporate Governance
- Critical Thinking
- Drug Discovery Development
- Fact-Based Decision Making
- Healthcare Trends
- Interpersonal Influence
- Organizing
- Public Policies
- Regulatory Compliance
- Regulatory Development
- Scientific Research
- Strategic Thinking
- Subject Matter Experts (SME) Collaboration
- Technical Writing
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