Senior US Regulatory Affairs Lead — Allergy Portfolio

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

Job summary

Opella seeks a US Regulatory Affairs Senior Manager – Allergy to lead regulatory strategies for NDA/ANDA and OTC products, including Allegra, Xyzal, and Nasacort. You will collaborate with cross-functional teams, manage labeling and promotional reviews, and maintain FDA communications.

The role requires experience across NDA/ANDA, labeling, and product lifecycle management, with strong English proficiency and a record of leading regulatory initiatives in consumer healthcare.

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• 5–8 years of Regulatory Affairs experience across multiple product categories (NDA, ANDA, Monograph, etc.).
• 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.
• Experience managing regulatory activities across multiple product types and pathways.
• Fluent in English; additional languages are a plus.

Responsibilities

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

Skills

Regulatory affairs

Cross-functional leadership

FDA interactions

Regulatory strategy

Advertising/promotion review

Project management

Education

Bachelor’s degree

Advanced degree (MS/Pharm.D./MD/Ph.D.)

Job description

Opella seeks a US Regulatory Affairs Senior Manager – Allergy to lead regulatory strategies for NDA/ANDA and OTC products, including Allegra, Xyzal, and Nasacort. You will collaborate with cross-functional teams, manage labeling and promotional reviews, and maintain FDA communications.

The role requires experience across NDA/ANDA, labeling, and product lifecycle management, with strong English proficiency and a record of leading regulatory initiatives in consumer healthcare.