Global Regulatory CMC Lead

Opella•Morristown, NJ

About The Position

Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally. Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. As a globally certified B Corp company, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com. About the Job: 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

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

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