Regulatory Lead, Early Strategy & External Engagement

Regulatory Lead, Early Strategy & External Engagement

Location: Morristown, NJ

Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally. 

Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting.

At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.

B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com.

About the Job

We are seeking an inspiring, self-driven, career minded professional who will leverage his/her experience in regulatory affairs to proactively lead & contribute to North America (NA) business growth. The role is accountable to deliver Regulatory Affairs strategies for early-stage innovation projects for Regional and Global brands in NA, such as new active ingredients, new technology and geographic expansions. The role is also responsible for oversight and coordination of NA Regulatory Intelligence and external engagement activities.

Main Responsibilities:

• Lead the creation of novel regulatory strategies for new to NA business innovations, including new active ingredients, new technologies and geographic expansions
• Represent NA Regulatory Affairs on key early-stage innovation initiatives
• Work collaboratively with cross-functional internal stakeholders and external experts to drive product, labeling, and claims innovation, balancing Probability of Success (POS) & risk identification/mitigation
• Lead and manage the preparation for meetings with US FDA and Health Canada
• Work across all regulatory classes: NDA/ANDA, Drug Monograph, Medical Device, Dietary Supplements & Cosmetics.
• Input into business development evaluations assessing regulatory pathway, risks and opportunities
• Monitor and track changes/planned changes to federal/state regulations that have the potential to impact the regulatory status of existing business or pathway to market for future products
• Work closely with key internal stakeholders (Global Regulatory Affairs, US Government Affairs, Science Hub, Quality, Legal, Communications, etc.) to assess impact of changes/proposed changes to regulations, input into external engagement strategy/mitigation and drive to aligned company positions
• Represent Opella at key external industry bodies (Consumer Health Products Association, Regulatory Affairs Professional Society, etc.)
• Deliver projects/other duties as required based on internal or external requirements for NA Regulatory Affairs.

About You:

• Minimum B.A. or B.S.; M.A or M.S., Pharm D, MD, PhD or equivalent preferred
• Minimum of 7-10 years of experience in regulatory affairs across multiple regulatory classes (NDA, Monograph, Device, Cosmetic, Food, Dietary Supplement), with 4 years of direct regulatory experience with US/Canada over-the-counter drugs.
• Fluent English required; additional languages a plus

Why us?

At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.

We Are Challengers.

We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things:

All In Together: We keep each other honest and have each other's backs.

Courageous: We break boundaries and take thoughtful risks with creativity.

Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity.

Radically Simple: We strive to make things simple for us and simple for consumers, as it should be.

Join us on our mission. Health. In your hands.

www.opella.com/en/careers

Opella Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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