Senior Manager, US Regulatory Affairs – Allergy

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

Job summary

Opella Healthcare Group seeks a Senior Manager of US Regulatory Affairs (Allergy) to lead regulatory strategies for NDA/ANDA products, drive cross-functional collaboration and engage with the FDA. The role requires navigating labeling, advertising reviews, and lifecycle management for OTC/consumer health products.

You will mentor teams, influence product development, and help shape a sustainable, impactful self-care portfolio across Allegra, Xyzal and Nasacort lines.

Qualifications

• Bachelor's degree required; advanced degree preferred.
• 5–8 years of Regulatory Affairs experience across multiple product categories.
• At least 4 years of direct Regulatory Affairs experience supporting OTC NDA drug products.

Responsibilities

• Develop regulatory strategies for innovation and maintenance of business projects with NDA/ANDA pathways.
• Represent US Regulatory Affairs on cross-functional project teams.
• Lead regulatory submissions for NDA drugs, including drafting content as required.
• Act as regulatory reviewer/approver for advertising/promotion on assigned portfolio.
• Oversee labeling activities including Drug Facts Labeling and label changes.
• Lead interactions with US FDA, including preparation and conduct of FDA meetings (Type B/C).
• Monitor regulatory environment to identify trends impacting portfolio.

Skills

Regulatory strategy

Cross-functional lead

FDA/Regulatory interactions

US NDA/ANDA

Labeling review

English fluency

Education

Bachelor's degree required

Advanced degree preferred

Job description

Opella Healthcare Group seeks a Senior Manager of US Regulatory Affairs (Allergy) to lead regulatory strategies for NDA/ANDA products, drive cross-functional collaboration and engage with the FDA. The role requires navigating labeling, advertising reviews, and lifecycle management for OTC/consumer health products.

You will mentor teams, influence product development, and help shape a sustainable, impactful self-care portfolio across Allegra, Xyzal and Nasacort lines.