Regulatory Affairs Lead

Regulatory Affairs Lead

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

The Regulatory Affairs Lead oversees all activities related to regulatory compliance and operation across Gold Bond’s brand portfolio. This role is responsible for preparing, reviewing and submitting regulatory documents, maintaining up-to-date knowledge of regulatory requirements, and liaising with regulatory authorities.

Main Responsibilities:

• Provide strategic regulatory leadership in cosmetic and OTC skin care sector working in multi-disciplinary teams to identify innovative and sustainable new product opportunities, assisting with the successful development and approval of new products.
• Proactively drive Gold Bond's brand vision by understanding evolving healthcare and consumer needs, assessing their impact on the product portfolio, anticipating necessary adjustments to the product vision based on consumer feedback, and influencing the external regulatory environment.
• Develop and implement effective regulatory strategies to support the brand and development teams, addressing both strategic and tactical product issues, including policy, product/project strategy, labeling, and advertising.
• Works externally across US Trade Associations to identify, influence and resolve regulatory issues and strategic opportunities to promote self-care and differentiate our Gold Bond Brand in the industry
• Responsible for all regulatory decision making and problem solving needed to support the brand product portfolio
• Develop the regulatory strategy and ensure effective execution for new innovative consumer-centric products and the life cycle management of products in the Gold Bond portfolio
• Responsible for regulatory approval and maintenance of all product claims, ingredient and consumer-facing claims.
• Drive and develop the most effective regulatory strategy for cosmetic and OTC skin products
• Responsible for timely and effective communication with health authorities including the submission of highly ethical and scientifically robust documents, as well as the timely responses (telephone, written, meetings, etc.) to assure expedient and efficient review of products
• Provide the regulatory strategy and intelligence for due diligence and business development initiatives
• Ensure product registrations/ licenses are delivered and maintained to meet product launches, market expansion and product stewardship

About You:

• Minimum B.S.; M.S.in Regulatory, Science or related field.

• Minimum 8-10 years in Regulatory Affairs, including leadership roles
• Established experience in cosmetic and OTC skin products
• Established experience is Regulatory Operations including product registration and document management
• Regulatory Certification (RAC) preferred however not essential

• Deep knowledge of regulatory requirements to support cosmetic and OTC skin product development and life-cycle management
• Recognized strategic leadership and effective collaboration
• Ability to communicate effectively and provide clear write and verbal direction, insights and recommendation
• Critical and analytical thinker with the demonstrate track record of thinking outside the box, solving challenges problems and identifying new opportunities
• Demonstrated ability to lead cross functional team and effectively deliver outcomes

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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.