Sanofi
Regulatory Affairs Lead - Pain and Icy Hot page is loaded## Regulatory Affairs Lead - Pain and Icy Hotlocations:
Morristown, NJtime type:
Full timeposted on:
Posted Todaytime left to apply:
End Date: March 31, 2026 (30+ days left to apply)job requisition id:
R2835316Opella 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:**The Regulatory Affairs Lead - Pain and Icy Hot provides Regulatory Affairs oversight for the Pain portfolio in the US, including the Icy and Aspercreme.
Key accountabilities include representing US Regulatory Affairs on innovation project teams and in advertising/promotion reviews. Responsibilities include creation of the regulatory strategy for new product launches, oversight/creation of product labeling and assuring all aspects of maintenance activities to keep the products up to date and compliant.
The role is expected to be able to prioritize/balance activities across innovation and base business support, as well as supporting the assessment for any changes in regulations for impact to assigned product portfolio.# **Main Responsibilities:*** Develop regulatory strategies for innovation and maintenance of business projects by leveraging a strong understanding of the US OTC drug monograph system and NDA/ANDA drug registration pathways.* Represent US Regulatory Affairs as a cross-functional member on project teams* Act as the regulatory affairs reviewer/approver for advertising/promotion on assigned product portfolio* Oversight of labeling activities for assigned products, including creation of Drug Facts Labeling for new product launches and assessing/reviewing/approving label changes to marketed products.* Support the monitoring of the US regulatory environment to identify and asses impact of any trends/proposed changes that could impact assigned portfolio of products* Support other projects/duties as needed, such as external engagement activities# **About You:*** **Education:*** + Minimum B.A. or B.S.; M.A or M.S., Pharm D, MD, PhD, or equivalent preferred* **Experience:*** + Minimum 5-8 years of experience in regulatory affairs across multiple regulatory classes (NDA, Monograph, Device, Cosmetic and/or Food/Dietary Supplement), with at least 4 years of direct regulatory affairs experience with over-the-counter drugs
+ Fluent English required; additional languages a plus 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.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.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:125,013.00 - 142,688.00 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: March 31, 2026 (30+ days left to apply)job requisition id:
R2835316Opella 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:**The Regulatory Affairs Lead - Pain and Icy Hot provides Regulatory Affairs oversight for the Pain portfolio in the US, including the Icy and Aspercreme.
Key accountabilities include representing US Regulatory Affairs on innovation project teams and in advertising/promotion reviews. Responsibilities include creation of the regulatory strategy for new product launches, oversight/creation of product labeling and assuring all aspects of maintenance activities to keep the products up to date and compliant.
The role is expected to be able to prioritize/balance activities across innovation and base business support, as well as supporting the assessment for any changes in regulations for impact to assigned product portfolio.# **Main Responsibilities:*** Develop regulatory strategies for innovation and maintenance of business projects by leveraging a strong understanding of the US OTC drug monograph system and NDA/ANDA drug registration pathways.* Represent US Regulatory Affairs as a cross-functional member on project teams* Act as the regulatory affairs reviewer/approver for advertising/promotion on assigned product portfolio* Oversight of labeling activities for assigned products, including creation of Drug Facts Labeling for new product launches and assessing/reviewing/approving label changes to marketed products.* Support the monitoring of the US regulatory environment to identify and asses impact of any trends/proposed changes that could impact assigned portfolio of products* Support other projects/duties as needed, such as external engagement activities# **About You:*** **Education:*** + Minimum B.A. or B.S.; M.A or M.S., Pharm D, MD, PhD, or equivalent preferred* **Experience:*** + Minimum 5-8 years of experience in regulatory affairs across multiple regulatory classes (NDA, Monograph, Device, Cosmetic and/or Food/Dietary Supplement), with at least 4 years of direct regulatory affairs experience with over-the-counter drugs
+ Fluent English required; additional languages a plus 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.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.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:125,013.00 - 142,688.00 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