US Regulatory Affairs Lead – Allergy

Opella • Morristown, NJ

5d • $183,750 - $265,417 • Hybrid

About The Position

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. Lead the U.S. Regulatory Affairs strategy for the allergy portfolio, including Allegra, Xyzal, and Nasacort, by providing regulatory oversight for new product development, representing Regulatory Affairs on cross-functional project teams, and supporting advertising and promotional review activities. Develop and execute regulatory strategies for product launches, lead FDA interactions, oversee product labeling and lifecycle maintenance, ensure regulatory compliance, and balance innovation initiatives with ongoing support for existing products while assessing the impact of changing regulations.

Requirements

• Bachelor's degree required; advanced degree (M.S., Pharm.D., M.D., Ph.D., or equivalent) preferred.
• 10+ years of Regulatory Affairs experience across multiple product categories, including NDA, Monograph, medical devices, cosmetics, and/or food/dietary supplements, with at least 6 years supporting OTC NDA drug products.
• Proven experience leading FDA interactions, including developing regulatory strategies, preparing meeting requests and briefing packages, and representing the organization during FDA meetings.
• Strong knowledge of U.S. regulatory requirements, product lifecycle management, and regulatory submissions for OTC products.
• Experience leading, mentoring, or overseeing junior regulatory professionals in either direct leadership or matrixed team environments.
• Fluent in spoken and written English; additional language skills are a plus.

Responsibilities

• Develop integrated regulatory strategies for the US allergy portfolio, including innovation and maintenance of business projects, by leveraging a strong understanding of the New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) registration pathways.
• Accountable for US FDA interactions for the allergy portfolio, including leading/overseeing all meetings and correspondence
• Oversee objectives, development and activities of one direct report, including providing guidance on product/project strategies
• Represent US Regulatory Affairs as a cross-functional member on project teams
• Act as the regulatory affairs reviewer/approver for advertising/promotion on assigned product portfolio
• Oversight of labeling strategy for assigned products, including creation/testing of Drug Facts Labeling for new product launches (label comprehension and self-selection studies) and assessing/reviewing/approving label changes to marketed products
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager