US Regulatory Affairs Lead – Allergy

Location: Morristown, NJ

About the role

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 US Regulatory Affairs Lead – Allergy, you’ll bring your skill, curiosity, and drive to make health simpler, smarter, and more human.

• Lead initiatives that advance our brands and strengthen our reputation worldwide.
• Mentor and uplift emerging talent while pushing your own growth and influence.
• Put purpose into practice — embedding sustainability, access, and social impact into every decision.
• Model the challenger mindset: question complexity, act with integrity, and make things radically simple.
• Help shape a culture that’s ambitious, collaborative, and serious about recognition and belonging.
• Lead the U.S. Regulatory Affairs strategy for the allergy portfolio, including Allegra, Xyzal, and Nasacort, by providing regulatory oversight for new product development, representing Regulatory Affairs on cross-functional project teams, and supporting advertising and promotional review activities.
• Develop and execute regulatory strategies for product launches, lead FDA interactions, oversee product labeling and lifecycle maintenance, ensure regulatory compliance, and balance innovation initiatives with ongoing support for existing products while assessing the impact of changing regulations.

Responsibilities

• Develop integrated regulatory strategies for the US allergy portfolio, including innovation and maintenance of business projects, by leveraging a strong understanding of the New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) registration pathways.
• Accountable for US FDA interactions for the allergy portfolio, including leading/overseeing all meetings and correspondence.
• Oversee objectives, development, and activities of one direct report, including providing guidance on product/project strategies.
• 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 strategy for assigned products, including creation/testing of Drug Facts Labeling for new product launches (label comprehension and self-selection studies) and assessing/reviewing/approving label changes to marketed products.
• Support the monitoring of the US regulatory environment to identify and assess the impact of any trends/proposed changes that could impact the assigned portfolio of products.
• Support other projects/duties as needed, such as external engagement activities.

Requirements

• Bachelor's degree required; advanced degree (M.S., Pharm.D., M.D., Ph.D., or equivalent) preferred.
• 10+ years of Regulatory Affairs experience across multiple product categories, including NDA, Monograph, medical devices, cosmetics, and/or food/dietary supplements, with at least 6 years supporting OTC NDA drug products.
• Proven experience leading FDA interactions, including developing regulatory strategies, preparing meeting requests and briefing packages, and representing the organization during FDA meetings.
• Strong knowledge of U.S. regulatory requirements, product lifecycle management, and regulatory submissions for OTC products.
• Experience leading, mentoring, or overseeing junior regulatory professionals in either direct leadership or matrixed team environments.
• Fluent in spoken and written English; additional language skills are a plus.

Pay

The salary range for this position is $183,750.00 - $265,416.66 USD annual.

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 into 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 are 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 toward healthier people and planet.