For more than a hundred years, L’Oréal believes that beauty needs Science. In a world now transformed by digital technology and the emergence of new scientific Domains, we are confident in our ability to turn these opportunities into major innovations, closely linked to the new consumer expectations all over the world. Science & Technology are allowing us to invent safe, trustable, sustainable & responsible beauty products and experiences that will change people’s lives.
L’Oréal R&I has continuously invested upstream in its research with a high level of ambition. Our 3800 L'Oréal R&I people are talented and highly skilled, located in major markets, working in a cooperative way, opened to the world.
The Principal Scientist of Regulatory Affairs has responsibility for ensuring the compliance of our products by way of ensuring the appropriate systems and mechanisms are in place for effective implementation of current and upcoming compliance measures. This position is based in Clark, New Jersey. The Principal Scientist should also have working knowledge of evaluating and supporting OTC products and medical devices. This position would also support issue management topics for the America’s to ensure appropriate action plans are in place for compliance.
You Will . . .
- Ensure products placed on the market comply with local, country and/or federal regulations
- Provide the expertise required to defend Group’s regulatory policy and projects before the relevant authorities and stakeholders
- Reinforce and strengthen relationships with key external stakeholders
- Proactively monitor changes in the regulatory environment and provide insights and recommendations on how to address them appropriately
- Develop a strong interface with the other US-based organizations, particularly R&I and Business divisions
- Provide assistance, as needed, for Country/Zone Scientific Directors, acting as a key partner and subject matter expert
- Lead cross-disciplinary projects initiated within the Regulatory Affairs network
- Identify the need for new regulatory procedures, SOPs, and participates in development and implementation.
- Determine requirements and options for regulatory submission, approval pathways, and compliance activities, particularly for INDs, NDAs and Medical Devices
- Ensure the functional team organization and skills are fully aligned with the needs of the country/zone and region, working closely with the respective leaders
- Assist in managing crisis situations when they occur
You Have . . .
- Advanced degree in a relevant scientific discipline, with 10+ years of progressive experience
- Relevant regulatory affairs expertise in the cosmetic, OTC, or consumer/personal health care industries, medical device and/or pharmaceutical industries, with global vision of the profession
- Demonstrated experience and expertise in the preparation and submission of complex regulatory documents such as INDs, NDAs, IDEs, PMAs, 510(k)s and/or any other major regulatory submissions.
- Excellent communication (verbal and written) and interpersonal skills
- Ability to analyze and summarize complex RA requirements and initiatives for key business target audiences.
- Proven leader with a strong results orientation, positive “hands on” attitude and a sense of urgency to get things done with demonstrated grace and even temperament under pressure.
You Are . . .
- Able to execute and build on business partnerships within R&I
- Able to monitor and report on emerging developments and regulatory affairs, including introduction of new legislation and/or regulations of importance to L’Oréal’s strategic decisions.
- Able to network and build contacts with relevant external and internal stakeholders to identify and address issues as warranted.
- Self-motivated person who empowers and inspires high performance teams; can influence by means of logic / rationale backed by analysis and data as opposed to leveraging authority and directive command.
- An effective communicator who has an ability to express themselves clearly, provide clarity and alignment in their activities, and proactively collaborates with business and functional stakeholders to define and implement a holistic approach to Regulatory and Scientific Affairs in Americas.
- Able to contribute to an energized environment with high morale and ethics based on the defined business and functional strategy and focused on teamwork and alliance building capabilities in a matrix organization. A team player who is trustworthy, reliable, and competent.
- An effective leader who brings optimism and excitement to others, with an ability to present himself/herself professionally and confidently in large public forums, including representation in the cosmetic community and at the senior levels of the government and public community.
- Full proficiency in English
- Authorized to work in the US on a permanent, ongoing basis, without the need for sponsorship now or in the future
We are an Equal Opportunity Employer and take pride in a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, sexual orientation, national origin, age, marital or veteran status, medical condition or disability, or any other legally protected status.
If you require a reasonable accommodation to complete an application for a recognized disability under applicable law, please email [email protected]. Please note this email will only respond to specific requests for assistance completing the application as a request for accommodation for a disability. All others will not be considered.