US Regulatory Affairs Senior Manager - Allergy

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. North America Applicants Only Salary The salary range for this position is: $ 127,500.00 - $ 184,166.66 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 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 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. B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet. Find out more about our mission at Company Culture 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. #J-18808-Ljbffr (1023) Chattem, Inc