Sanofi Group Regulatory Lead Rx to OTC Switch in Bridgewater, New Jersey
The Regulatory Lead Rx to OTC Switch is responsible for the development and execution of regulatory strategies to support switch for assigned project(s). This individual will work cross-functionally with the Global Switch Team and Business Unit Lead(s) to ensure that the regulatory strategies align with the commercial goals.
This individual must possess a comprehensive understanding of the regulatory environment related to self-care. Have a proven track record in successful Agency interactions and negotiations. Possess the ability to work autonomously with strategic direction from the functional leads.
Key responsibilities include:
Provide robust regulatory assessment of therapeutic areas, target molecules, new enabling technologies for innovative switch opportunities.
Develop the best in class regulatory strategies working directly with the global and regional switch teams to ensure the efficient delivery of switch innovation for designated markets.
Contributes to the development of strategic plans and preparation of supporting documentation for consumer studies.
Actively monitor the regulatory landscape for a switch and participate in influencing activities for regulatory reform in areas of interest to the business.
Prepare detailed regulatory risk evaluations and risk mitigation strategies in the context of switch environment.
Represent the company at Health Agency meetings, prepare for the planning and conduct of meetings, as appropriate.
Initiate and respond to regulatory agency contacts (telephone, written, meetings, etc.) to assure expedient and efficient review and approval of products. Ensure that all documents to be submitted to regulatory agencies have been evaluated to assure completeness, scientific accuracy, regulatory compliance with global and/or local submission standards, and are organized in a manner to facilitate agency review.
Provide the company with current and proposed regulatory, scientific and pertinent legal issues including analysis of the potential impact on the business
COMPETENCE FOR SUCCESS
Inspiring professional who will leverage his/her regulatory experience and commercial awareness to actively contribute to CHC business growth. Strategic & Technical Regulatory Affairs Expertise: Demonstrated success in developing regulatory strategies in OTC environments, Rx to OTC switch is a plus; possesses a strong knowledge of the regulatory requirements to support the regions Communication & Influencing: The successful candidate will possess strong communication, negotiation and influencing skills. He/she will be at ease working in a matrix environment and display the necessary multicultural sensitivity in context of Global environment. Competencies:
Act for Change
Strive for Results
Commitment to Customer
Other Personal Characteristics:
High standards of integrity
Strong interpersonal skills
Excellent oral and written presentation skills
Dedicated and persuasive “can-do” attitude
Self-motivated; entrepreneurial spirit; excellent time management skills
Organizational savvy; be able to work in a high matrix structure including sharing knowledge with relevant stakeholders
“Think out of the box” mindset
Minimum BA or BS; MS, Pharm D, MD, Ph.D. or equivalent preferred
Regulatory Certification (RAC) preferred
Minimum 7 years in Regulatory Affairs, including leadership roles
Fluent English required; additional languages desirable.
Manage matrix teams and partnering with cross-functional teams at a highly strategic level.
Sanofi 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.
Sanofi Glassdoor: #GD-SA
Sanofi LinkedIn: #LI-SA
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life