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
www.opella.com
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About the Job:
Are you ready to shape the future of Consumer Health? Your skills could be critical in helping our teams accelerate progress.
The Global Switch Science Regulatory Lead will drive regulatory strategy and execution to support CHC business growth, particularly in Rx-to-OTC switch programs. This role involves leading regulatory submissions, preparing and managing IND and NDA documents, engaging with regulatory agencies, and reviewing product labeling and advertising.
Inspiring professional who will leverage his/her regulatory experience and commercial awareness to proactively contribute to CHC business growth. The Global Switch Science Regulatory Lead is responsible for helping develop and execute the regulatory strategy of the switch development program.

Main Responsibilities:

• Assist 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, includes 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 or programs
• Contributes to interdepartmental projects and supports the provision of scientific, and technical information.
• Represent Regulatory Affairs by participating as a team member on approved projects and programs.

About You:

• B.S. required; MS/advance degree preferred
• About 6 - 8 years of relevant regulatory experience across multiple regulatory classes (NDA, Medical Device, OTC). Experience in Rx-to-OTC switches, software medical devices or diagnostics is preferred.
• Excellent written and verbal communication skills, with the ability to present complex information clearly and concisely to both internal and external stakeholders.

Why us?
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.
www.opella.com/en/careers
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.

GD-SA

LI-SA

• Assist 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, includes 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 or programs
• Contributes to interdepartmental projects and supports the provision of scientific, and technical information.
• Represent Regulatory Affairs by participating as a team member on approved projects and programs