AVP, Regulatory Affairs Americas
I. Major Function:
The Regulatory Affairs Head for Americas, covering the USA, Canada and Latin America Zone (consisting of Brazil, Mexico and the Hispanic zone) has full functional responsibilities, including managing and leading network of Scientific & Regulatory Affairs departments within the region, in line with the Corporate regulatory strategy and the requirements of each country and zone part of the Americas.
II. Principal Accountabilities:
- Provide overall strategic functional direction and set objectives for the Regulatory Affairs function within SRC Americas with regard to cosmetics, OTC monograph products, drugs, medical devices and chemicals throughout the product lifecycle
- Ensure products placed on the market comply with local, country and/or federal regulations
- Lead and develop a team of specialists responsible for regulatory dossiers and for monitoring, analyzing and handling regulatory matters via Regulatory Intelligence
- Provide the expertise required to defend Group’s regulatory policy and projects before the relevant authorities and stakeholders
- Give short-term and long-term benefit for the Americas business by influencing and shaping the regulatory environment based on needs, priorities and regional direction
- Reinforce and strengthen relationships with key external stakeholders
- Proactively monitor changes in the regulatory environment at the Americas and international level 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 division
- Manage all activities pertaining to L’Oréal interactions and communications with FDA and other regulatory agencies in the United States, and other global regulatory agencies, trade associations and the academic world as needed
- Provide assistance, as needed, for Country/Zone Scientific Directors, acting as a leading figure and subject matter expert
- Define the department’s objectives and ensure the team organization and skills match the needs by enhancing quality, improving service, optimizing costs and developing the skills of team members
- Lead cross-disciplinary projects initiated within the Regulatory Affairs network
- Ensure solid and comprehensive orientation of new employees, talents, management and leadership growth opportunities are provided to achieve L’Oréal’s mission.
- 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
- Act as an advisor in managing crisis situation when they occur
III. The ideal candidate for AVP, Regulatory Affairs Americas will need the following competencies to succeed:
Functional Competency, as illustrated by:
- Will be both a strategist and tactician possessing a demonstrated track record in developing a roadmap in Regulatory Affairs within Americas/USA; must be a functional subject matter expert. Must be able to outline and execute functional agenda and initiatives in partnership with the business, corporate function and Headquarters.
- Displays an ability 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. Then exhibit capability to advice on specific legislative issues and related crisis management.
- Demonstrates networking and background and proposal-specific lobbying. Shows active participation in meetings, conferences, business lunches, receptions etc. and continuously build contacts with relevant external and internal stakeholders to identify and address issues as warranted.
Collaboration and Influencing Skills as evidenced by:
- 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 and networker who have an ability to express him/herself clearly, provide clarity and alignment in everything he/she does, and proactively collaborates with business and functional stakeholders to define and implement a holistic approach to Regulatory and Scientific Affairs in Americas.
- 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.
- Build productive and respectful partnerships with key internal and external stakeholders to ensure that the Company’s strategic business imperative are met through sharing of knowledge, expertise, and relevant information.
Personal Attributes, as supported by:
· A passionate and persistent individual who has demonstrated that he/she can thrive in rapidly changing, fast growing and fluid environment; possesses high level of professional and personal integrity, positive energy, and a sense of winning, coupled with flexibility, sensitivity and openness in approach.
· Exhibits high ethics and grounded judgment when making decisions, including demonstration of sticking to core company values and code of conduct. Takes appropriate risks and follows through on commitment despite difficulties or complications.
· A 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.
IV. Training and Experience:
• Advanced degree in a relevant scientific discipline, with 10+ years of progressive experience
• Experience in leading, managing and developing high performing cross-functional and multi-cultural teams.
• Relevant regulatory affairs expertise in the cosmetic, OTC, consumer health care, 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 a plus.
• Ability to develop a strategic vision
• 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.
• Aptitude for cross-disciplinary and network operations
• Full proficiency in English
Additional Spanish language skills a plus
• Must be legally eligible to work in the US on an on-going basis
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 USApplicationAccommodation@support.lorealusa.com. 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.