Location: Morristown, NJYou've built experience, now use it where bold ideas meet real impact. At Opella, we're challenging how self-care works for millions of people and need leaders and experts ready to shape what's next. As an US Regulatory Affairs Lead - Allergy, you'll bring your skill, your curiosity and your drive to make health simpler, smarter and more human.
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.
- 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.
Main 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
About you: - 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.
This is more than the next step in your career, it's a chance to lead change and help reinvent self-care for the world. If you're ready to challenge, inspire and deliver impact that matters, we're ready for you.
We are challengers. We are Opella.Opella values diversity in all its forms and is committed to fostering a workplace where everyone can belong and excel. We welcome and encourage applications from people of all backgrounds.
North America Applicants Only
The salary range for this position is:
$183,750.00 - $265,416.66 USD Annual
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