Global Regulatory CMC Lead

Opella • Morristown, NJ

1d

About The Position

Join our mission to make healthcare as simple as it should be through innovative OTC medicines and nutritional products that that reach millions of consumers worldwide. We are looking for an experienced Global Regulatory CMC Lead to join Opella´s Global Regulatory CMC Team. You'll be the CMC regulatory expert to ensure our OTC medicinal products and nutritional products get to market efficiently while maintaining the highest quality standards.

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
• 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

Nice To Haves

• Capability to mentor and train staff is a plus.
• Experience with GenAI tools in the CMC regulatory environment is a plus
• Further languages are a plus

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level