Opella · 9 hours ago
Global Regulatory CMC Lead
Morristown, NJ
Full-time
Hybrid
Senior Level
$120K/yr - $180K/yr
5+ years expOpella is a self-care challenger with a significant portfolio in the OTC and VMS market. They are seeking an experienced Global Regulatory CMC Lead to manage CMC regulatory strategies and ensure efficient market access for their products while maintaining high-quality standards.
Health CarePersonal HealthRetail
Responsibilities
Lead the global CMC regulatory strategy for innovation and lifecycle management projects
Partner with cross-functional teams to accelerate product development timelines
Manage regulatory submissions across major markets (FDA, EU, etc.)
Provide expert guidance on CMC regulatory requirements, timelines and risk mitigation
Represent Opella in regulatory authority meetings and scientific advice meetings
Provide CMC regulatory contribution, review and expert recommendation to the CMC writer within Development and Manufacturing & Supply units
Lead CMC dossier development for clinical trials, product registrations and changes
Manage regulatory databases for planning and tracking of regulatory submissions
Provide CMC claim recommendations to Brand Teams
Perform Due Diligence of regulatory CMC dossiers
Drive CMC regulatory intelligence to anticipate and adapt to changing global requirements
Strategic and think-out-of-the-box mindset with strong business acumen
Excellent communication skills for diverse stakeholder management
Proven ability to work effectively in teams and matrix organizations
Self-motivated with entrepreneurial spirit
Excellent oral and written presentation skills
Capability to mentor and train staff is a plus
Qualification
Required
Bachelor's Degree or Advanced degree (MS/PhD) in Pharmaceutics, Chemistry, or related scientific field
5+ years global regulatory CMC experience with proven FDA/EU approval track record
Hands-on experience with OTC medicines and nutraceutical products for innovation and life-cycle management
Proficiency in using Veeva RIM and other digital tools (eCTD viewer, MS Word, Excel, PowerPoint, Sharepoint)
Fluency in oral and written English
Excellent communication skills for diverse stakeholder management
Proven ability to work effectively in teams and matrix organizations
Self-motivated with entrepreneurial spirit
Excellent oral and written presentation skills
Capability to mentor and train staff
Preferred
Experience with GenAI tools in the CMC regulatory environment
Further languages are a plus
Benefits
Company employee benefit programs
Company
Opella
Opella is a consumer healthcare business segment of Sanofi.
10001+ employees
Funding
Current Stage
Late StageTotal Funding
unknown2024-10-20Acquired
Recent News
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