Senior US Regulatory Affairs Manager, Allergy Innovations

Opella; Morristown (AZ); On-site; USD 150,000 - 217,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Leadership

Regulatory Affairs

Cross-functional collaboration

English proficiency

Education

Bachelor's degree

Advanced degree preferred

Job description

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.