Global Regulatory Lead

**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.B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet. Find out more about our mission at .## ***About the Job***The Global Regulatory Lead supports the regulatory strategy for bringing new drugs, medical devices, and combination products to market. It involves preparing and managing key submissions like INDs and NDAs while coordinating with internal teams. The position also helps plan and participate in meetings with regulatory agencies such as the FDA.## Additionally, it includes reviewing product labeling and advertising to ensure compliance, analyzing regulations, and monitoring competitor approvals. The role works cross-functionally to provide scientific and regulatory input on projects. Overall, it helps ensure products meet all regulatory requirements throughout their lifecycle. ***Main Responsibilities:**** Provide assistance in developing and implementing the regulatory strategy for new products/claims for different regulatory classes (drug, medical device, combination products).* Lead the operational execution of regulatory submissions for NDA products working with the electronic document specialists and publishers.* Prepare IND submission documents aligned with the regulatory strategy and support lifecycle management of the IND.* Support the planning of meetings with regulatory agencies as appropriate including participation in agency meetings on specific topics.* Review and approve labeling and advertising for NDA products. Review concept review, commenting and approval, competitive challenge research/responses.* Assist in the analysis and interpretation of government medical device regulations.* Research competitive product approval status and emerging FDA requirements to support switch programs.* Support Global Regulatory Affairs initiatives* Contributes to interdepartmental projects and supports the provision of scientific, and technical information.* Provide assistance and represent Regulatory Affairs by participating as a team member on approved projects and programs.***About You:**** 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.##At 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.North America Applicants OnlyThe salary range for this position is:111,000.00 - 130,000.00 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 theOpella 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.*#GD-SA**#LI-SA**#LI-HYBRID* #J-18808-Ljbffr