US Regulatory Affairs Senior Manager – Allergy

Opella; Morristown (AZ); Presencial; USD 150 000 - 217 000; Tempo integral

Resumo da oferta

Opella is seeking a US Regulatory Affairs Senior Manager – Allergy to lead regulatory strategies for an OTC portfolio, including Allegra, Xyzal, and Nasacort. You will represent Regulatory Affairs on cross-functional teams, review advertising, and support new product development.

You will oversee labeling and interact with the FDA, guiding NDA/ANDA submissions and ensuring regulatory compliance across multiple product categories, including OTC drugs.

Qualificações

• Bachelor’s degree required; advanced degree (MS, PharmD, MD, PhD or equivalent) preferred.
• 5–8 years of Regulatory Affairs experience across multiple product categories (NDA, ANDA, monograph, medical devices, cosmetics, food/dietary supplements).
• At least 4 years supporting OTC NDA drug products.
• Strong knowledge of U.S. regulatory requirements, submissions, labeling, and lifecycle management for consumer healthcare products.
• Fluent in English; additional languages a plus.

Responsabilidades

• Develop regulatory strategies for innovation and maintenance of business projects leveraging NDA/ANDA pathways.
• Represent US Regulatory Affairs as a cross-functional member on project teams.
• Lead regulatory submissions for NDA drugs, including drafting content as required.
• Act as reviewer/approver for advertising/promotion on the product portfolio.
• Oversee labeling activities including Drug Facts labeling and label changes.
• Lead interactions with FDA for the portfolio, including FDA meetings.

Conhecimentos

Leadership

Regulatory Affairs

Cross-functional collaboration

English proficiency

Formação académica

Bachelor's degree

Advanced degree preferred

Descrição da oferta de emprego

Salary Range

$150,000.00 - $216,666.66

All 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 teams
• Lead cross-functional teams for creation of regulatory submissions for NDA drugs, including drafting content as required
• 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.
• 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 products
• Support other projects/duties as needed, such as external engagement activities

About 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.