Regulatory Affairs Lead - Pain and Icy

Regulatory Affairs Lead – Pain and Icy Hot

2 days ago | Be among the first 25 applicants

Opella is the self-caring challenger with the purest and third-largest portfolio in the OTC & Vitamins, Minerals & Supplements market globally. Our mission is to bring health into people’s hands by making self-care as simple as it should be for half a billion consumers worldwide. At the core of this mission are our 100 beloved brands, our 11,000-strong global team, and 13 best-in-class manufacturing sites.

The Regulatory Affairs Lead – Pain and Icy Hot provides regulatory affairs oversight for the Pain portfolio in the US, including Icy and Aspercreme. The role represents US Regulatory Affairs on innovation project teams and reviews advertising/promotion. Responsibilities include developing regulatory strategy for new product launches, creating and updating product labeling, and ensuring all products remain compliant. The incumbent must prioritize and balance innovation and base business support activities and assess regulatory changes impacting the portfolio.

• Develop regulatory strategies for innovation and maintenance of business projects, 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 and promotion on the assigned product portfolio.
• Oversee labeling activities for assigned products, including creation of Drug Facts labeling for new product launches and approval of label changes.
• Monitor the US regulatory environment to identify and assess impacts of trends and proposed changes that could affect the portfolio.
• Support other projects and duties as needed, such as external engagement activities.

• Education: Minimum B.A. or B.S.; M.A./M.S., Pharm.
  
  D., MD, Ph.D., or equivalent preferred.
• Experience: 5–8 years regulatory affairs across multiple regulatory classes (NDA, monograph, device, cosmetic, food/dietary supplement) and at least 4 years OTC drug regulatory experience.
• Fluent in English required; additional languages a plus.

At Opella, you will enjoy challenging, purposeful work empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills in a bold, collaborative, inclusive culture where people thrive.

• We are Challengers, Dedicated to making self‑care simple.
• All in together: we keep each other honest and have each other’s backs.
• Courageous: we break boundaries and take thoughtful risks.
• Outcome‑obsessed: we are personally accountable, driving sustainable impact.
• Radically Simple: we simplify for us and for consumers.

Salary range: $125,013–$142,688 USD annually. All compensation is determined commensurate with experience. Employees may be eligible to participate in company employee benefit programs. Additional benefits information can be found through the link.

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, sexual orientation, disability, veteran or military status or liability for military status, domestic violence victim status, atypical cellular or blood trait, genetic information, or any other characteristic protected by law.