Summary

Opella is a consumer healthcare company specializing in retail health and personal care products. The company focuses on developing and distributing accessible healthcare solutions for everyday wellness needs. Operating in the retail health sector, Opella likely offers a range of over-the-counter products, personal care items, and health maintenance solutions designed for consumer use. While specific product details are not available, companies in this sector typically provide items such as vitamins, supplements, first aid products, personal hygiene items, and other health-related consumer goods. Opella appears to serve the growing market of consumers seeking convenient, retail-based healthcare options that bridge the gap between traditional medical products and everyday wellness. The company's positioning in retail health suggests a focus on making essential healthcare products more accessible to the general public through various retail channels, potentially including pharmacies, supermarkets, and online platforms.

Job description

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.

Requirements

Bachelor's degree required
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

Company overview

Opella is a consumer healthcare company specializing in retail health and personal care products. The company focuses on developing and distributing accessible healthcare solutions for everyday wellness needs. Operating in the retail health sector, Opella likely offers a range of over-the-counter products, personal care items, and health maintenance solutions designed for consumer use. While specific product details are not available, companies in this sector typically provide items such as vitamins, supplements, first aid products, personal hygiene items, and other health-related consumer goods. Opella appears to serve the growing market of consumers seeking convenient, retail-based healthcare options that bridge the gap between traditional medical products and everyday wellness. The company's positioning in retail health suggests a focus on making essential healthcare products more accessible to the general public through various retail channels, potentially including pharmacies, supermarkets, and online platforms.