US Regulatory Affairs Senior Manager – Allergy

Opella Healthcare Group; Morristown (TN); On-site; USD 150,000 - 217,000; Full time

Job summary

Opella Healthcare Group seeks a Senior Manager of US Regulatory Affairs (Allergy) to lead regulatory strategies for NDA/ANDA products, drive cross-functional collaboration and engage with the FDA. The role requires navigating labeling, advertising reviews, and lifecycle management for OTC/consumer health products.

You will mentor teams, influence product development, and help shape a sustainable, impactful self-care portfolio across Allegra, Xyzal and Nasacort lines.

Qualifications

• Bachelor's degree required; advanced degree preferred.
• 5–8 years of Regulatory Affairs experience across multiple product categories.
• At least 4 years of direct Regulatory Affairs experience supporting OTC NDA drug products.

Responsibilities

• Develop regulatory strategies for innovation and maintenance of business projects with NDA/ANDA pathways.
• Represent US Regulatory Affairs on cross-functional project teams.
• Lead regulatory submissions for NDA drugs, including drafting content as required.
• Act as regulatory reviewer/approver for advertising/promotion on assigned portfolio.
• Oversee labeling activities including Drug Facts Labeling and label changes.
• Lead interactions with US FDA, including preparation and conduct of FDA meetings (Type B/C).
• Monitor regulatory environment to identify trends impacting portfolio.

Skills

Regulatory strategy

Cross-functional lead

FDA/Regulatory interactions

US NDA/ANDA

Labeling review

English fluency

Education

Bachelor's degree required

Advanced degree preferred

Job description

Salary Range:$150,000.00 - $216,666.66All Compensation will be determined commensurate with demonstrated experience. You’ve built experience, now use it where bold ideas meet real impact. 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 an US Regulatory Affairs Senior Manager – Allergy, you’ll bring your skill, your curiosity and your drive to make health simpler, smarter and more human.About the job: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.Provide U.S. Regulatory Affairs support for the allergy portfolio, including Allegra, Xyzal, and Nasacort, by representing Regulatory Affairs on cross-functional innovation teams, participating in advertising and promotional reviews, and supporting new product development.Main responsibilities:Develop regulatory strategies for innovation and maintenance of business projects by leveraging a strong understanding US NDA/ANDA drug registration pathways.Represent US Regulatory Affairs as a cross-functional member on project teamsLead cross-functional teams for creation of regulatory submissions for NDA drugs, including drafting content as requiredAct as the regulatory affairs reviewer/approver for advertising/promotion on assigned product portfolioOversight 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.Lead interactions with US FDA for assigned portfolio, including supporting preparation and conduct of FDA meetings (Type B, Type C, etc.)Support the monitoring of the US regulatory environment to identify and asses impact of any trends/proposed changes that could impact assigned portfolio of productsSupport other projects/duties as needed, such as external engagement activitiesAbout you:Bachelor's degree required; advanced degree (M.S., Pharm.D., M.D., Ph.D., or equivalent) preferred.5–8 years of Regulatory Affairs experience across multiple product categories, including NDA, ANDA, Monograph, medical devices, cosmetics, and/or food/dietary supplements.At least 4 years of direct Regulatory Affairs experience supporting OTC NDA drug products.Strong knowledge of U.S. regulatory requirements, submissions, labeling, and product lifecycle management for consumer healthcare products.Experience managing regulatory activities across multiple product types and navigating different regulatory pathways.Fluent in spoken and written English; additional language skills are a plus.This is more than the next step in your career, it’s a chance to lead change and help reinvent self-care for the world. If you’re ready to challenge, inspire and deliver impact that matters, we’re ready for you. We are challengers. We are Opella.Opella values diversity in all its forms and is committed to fostering a workplace where everyone can belong and excel. We welcome and encourage applications from people of all backgrounds.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 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 www.opella.com .