What are the responsibilities and job description for the Global Regulatory Lead position at Opella?
You’ve built experience, now use it where bold ideas meet real impact. At Opella, we’re challenging how self-care works for millions of people and need leaders and experts ready to shape what’s next. As a Global Regulatory Lead, you’ll bring your skill, your curiosity and your drive to make health simpler, smarter and more human.
About The Job
We are challengers. We are Opella.
Opella Inc. 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 Only
The salary range for this position is: $111,000 - 160,333.33
All Compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs.
About Us
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.
#GD-SA
About The Job
- Supports regulatory strategy for bringing new drugs, medical devices, and combination products to market
- Prepares and manages key regulatory submissions such as INDs and NDAs
- Coordinates with cross-functional internal teams to support regulatory activities
- Helps plan and participate in meetings with regulatory agencies (e.g., FDA)
- Reviews product labeling and advertising to ensure regulatory compliance
- Monitors regulations and competitor approvals to inform strategy
- Provides scientific and regulatory input across projects and ensures compliance throughout the product lifecycle
- Support development and execution of regulatory strategies for drugs, medical devices, and combination products
- Lead and support regulatory submissions (e.g., NDA, IND), including preparation and coordination with publishing teams
- Assist with lifecycle management of INDs and participation in regulatory agency meetings
- Review and approve product labeling, advertising, and promotional materials for compliance
- Analyze regulatory requirements and monitor competitor approvals to inform strategy
- Contribute to cross-functional projects by providing scientific and regulatory input
- Support broader Global Regulatory Affairs initiatives and represent the function on key programs
- Bachelor's Degree Required
- About 3-5 years of relevant regulatory experience across multiple regulatory classes (NDA, Monograph, Medical Device).
- Good written and verbal communication skills, with the ability to present complex information clearly and concisely to both internal and external stakeholders.
- Experience in compiling regulatory dossier and executing FDA submission.
We are challengers. We are Opella.
Opella Inc. 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 Only
The salary range for this position is: $111,000 - 160,333.33
All Compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs.
About Us
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.
#GD-SA
Salary : $111,000 - $160,333