Sanofi Group Senior Director, CHC Global Regulatory Head - Medical Devices and Digital Health in Bridgewater, New Jersey
Global Regulatory Head – Medical Devices and Digital Health is responsible for the development and execution of regulatory strategies including CMC to support standalone medical devices, medical devices as combination products, innovative digital strategies within product portfolio or processes with significant focus on Rx-OTC Switch. This individual will work cross functionally with the Global Project Teams, Regulatory Teams and Business Partners to ensure that the regulatory strategies align to the commercial goals.
This individual must possess a comprehensive understanding of the regulatory environment related medical devices including software and systems and digital health globally with experience in self-care as a plus. Have a proven track record in successful Agency negotiations. Possess ability to work autonomously with strategic direction from the functional or regulatory leads.
Experiences as regulatory professional in technology companies is a plus.
Key responsibilities include:
Develop the best in class regulatory strategies working directly with the global and regional teams to ensure the efficient delivery of medical device and digital innovation for designated markets including defining the go-to-market regulatory strategies.
Provide company with current and proposed regulatory, scientific and pertinent legal issues including analysis of potential impact on the business
Technical understanding of design development and commercialization of medical devices with strong knowledge about health authority requirements including other applicable standards (ISO, IEC)
Proactively shape regulatory policy and actively monitor the regulatory landscape for medical devices and innovations in digital health 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 context of medical device environment
Represent company at Health Agency meetings.
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.
Contributes to the development of strategic plans and preparation of supporting documentation for consumer studies
COMPETENCIES 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 for medical devices, application in OTC environment or 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.
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 highly matrix structure including sharing knowledge with relevant stakeholders
“Think out of the box” mindset
Education and Experience:
Minimum BA or BS; MS, Pharm D, PhD or equivalent preferred
Regulatory Certification (RAC) preferred
Minimum 7 years in Regulatory Affairs, including leadership roles including Medical Devices and Digital applications
Fluent English required; additional languages desirable.
Recognized expert in managing 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.
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.