Sanofi Group Global Regulatory Strategy Lead Digestive Health, Bridgewater, NJ in Bridgewater, New Jersey
Product/projects regulatory management
Accountable for the development of the best regulatory strategies for projects/products within the assigned portfolio, in close collaboration with Global Regulatory Affairs and lead countries
Drive the regulatory strategies of all the DH global projects by being the first contact to the Innovation team
Accountable of the coordination of the preparation of Core-documents to be customized by Regions/countries for submissions to Regulatory Agencies and for managing responses to Regulatory Agencies questions on these Core documents
Contribute in the organization and attend scientific advice meeting with the Health Authorities
Contribute and validate the promotional and non-promotional programs for Global brands
Accountable for the coordination of the preparation of the Core documents for the maintenance events of the existing portfolio with a worldwide scope, such as renewals, variations, benefit/risk assessments, referrals, Discontinuation process, PRAC signals, PBRER/PSUSA/DSUR, etc.Regulatory Category Leadership
As a full member of the Category team, contributes to provide regulatory insights to drive and shape the Category strategy
Contribute to the development of the regulatory strategy for the respective portfolio, working collaboratively with GRA and cross functional teams to create project plans that identify opportunities, regulatory risks and mitigation strategies
Provide regulatory strategy and intelligence for due diligence and business development initiatives
Propose the strategy for HA Interaction and attend HA meetings as required ensuring that all projects have clearly defined regulatory paths to deliver and milestones are met leading to successful filings and approvals
Accountable to shape the regulatory environment to develop the CHC business specifically in the Probiotics area
Requirements & Qualifications:
Minimum MS; Pharm D, MD, PhD or equivalent
Minimum 10 years in CHC Regulatory Affairs, including leadership roles, and experience managing new projects developments.
Global experience on Probiotics is mandatory
Experience in US and EU regulations as well as OTC Environment is required
Experience in Digestive Health environment/products is a must
Recognized expert in managing matrix teams and partnering with cross functional teams at a highly strategic level.
Empowers teams to face challenges, make decisions and take action
Encourages collaboration and communication within and beyond the team
Strategic & Technical Regulatory Affairs Expertise
Demonstrated success in developing regulatory strategies in OTC environments across multiple regions; possesses a strong knowledge of Global regulatory requirements. He/she will bring creative & innovative ideas to the table to enable category strategies
Communication & Influencing
The successful candidate will possess strong communication, negotiation and influencing skills as demonstrated by his/her successful interaction with Marketing, Innovation, CMI, Industrial Affairs and Medical Affairs, enabling him/ her to drive the CHC vision for the Category. He/she will be at ease working in a matrix environment and display the necessary multicultural sensitivity in such a Global context.
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.
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