Global Regulatory CMC Lead page is loaded## Global Regulatory CMC Leadlocations:
Morristown, NJtime type:
Full timeposted on:
Posted Todaytime left to apply:
End Date: May 31, 2026 (30+ days left to apply)job requisition id:
R2841708## 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 .## ***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.## ***Main 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.## ***About You:**** 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).* Experience with GenAI tools in the CMC regulatory environment is a plus* Fluency in oral and written English* Further languages are a plusAt Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.**We Are Challengers.**We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things:**All In Together:** We keep each other honest and have each other's backs.**Courageous:** We break boundaries and take thoughtful risks with creativity.**Outcome-Obsessed:** We are personally accountable, driving sustainable impact and results with integrity.**Radically Simple:** We strive to make things simple for us and simple for consumers, as it should be.Join us on our mission. Health. In your hands.Opella and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.North America Applicants OnlyThe salary range for this position is:120,000.00 - 180,313.00 USD AnnualAll compensation will be determined commensurate with demonstrated experience. Employees may beeligible to participate in Company employee benefit programs. Additional benefits information can befound through the*#GD-SA**#LI-SA**#LI-HYBRID* #J-18808-Ljbffr
Morristown, NJtime type:
Full timeposted on:
Posted Todaytime left to apply:
End Date: May 31, 2026 (30+ days left to apply)job requisition id:
R2841708## 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 .## ***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.## ***Main 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.## ***About You:**** 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).* Experience with GenAI tools in the CMC regulatory environment is a plus* Fluency in oral and written English* Further languages are a plusAt Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.**We Are Challengers.**We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things:**All In Together:** We keep each other honest and have each other's backs.**Courageous:** We break boundaries and take thoughtful risks with creativity.**Outcome-Obsessed:** We are personally accountable, driving sustainable impact and results with integrity.**Radically Simple:** We strive to make things simple for us and simple for consumers, as it should be.Join us on our mission. Health. In your hands.Opella and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.North America Applicants OnlyThe salary range for this position is:120,000.00 - 180,313.00 USD AnnualAll compensation will be determined commensurate with demonstrated experience. Employees may beeligible to participate in Company employee benefit programs. Additional benefits information can befound through the*#GD-SA**#LI-SA**#LI-HYBRID* #J-18808-Ljbffr