Global Regulatory Therapeutic Lead H/F
Bridgewater, New Jersey
The Global Regulatory Lead (GRL) Sanofi CHC is in charge of the strategic and operational regulatory affairs activities for a portfolio of core Global brands and multi-Regional development and marketed products of the category.
Key responsibilities include:
Product/projects regulatory management
- As a regulatory portfolio owner, is accountable for the development of the global regulatory strategies for projects/products within the assigned portfolio, in close collaboration with affiliates.
- Is also accountable of the coordination of the preparation and on-time delivery of compliant submissions to Regulatory Agencies and for managing responses to Regulatory Agencies questions
- Is also accountable of the follow up of the implementation of the global strategy with RA affiliates.
- To ensure the one GRA voice, set-up and run GRA team meetings as needed
- Ensure timely execution of the GRPS milestones for the development projects as per Blue print
- Participate in the organization of scientific advice meeting with the Health Authorities
- Participate and validate the promotional and non-promotional programs for Global brands
- As a regulatory portfolio owner, is accountable for the maintenance of the existing portfolio with a worldwide scope, from the preparation to the submission/dispatch to affiliates on time such as renewals, variations, benefit/risk assessments, referrals, Discontinuation process, PRAC signals, PBRER/PSUSA/DSUR, etc.
- Manage the interactions as appropriate with the Countries GRA to ensure compliance with local requirements
- Work in compliance with Sanofi Quality Documents (QDs)
- Set-up and run Category Regulatory Portfolio team meetings on a routine basis to share category strategies and cross fertilize regulatory input and knowledge across regions
Regulatory Category Leadership
- As a full member of the Category team, contributes to provide regulatory insights to help 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
- Provides regulatory strategy and intelligence for due diligence and business development initiatives
- Proposes 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
- 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, 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.
- Minimum BS; MS, Pharm D, MD, PhD or equivalent preferred
- Minimum 5-7 years in Regulatory Affairs, including leadership roles, and experience managing and leading global team required.
- Fluent English required; additional languages desirable.
- Recognized expert in managing matrix teams and partnering with cross functional teams at a highly strategic level.
- Experience living in different global regions/ countries desirable
Sanofi s’engage en faveur de l'accueil et de l'intégration des personnes en situation de handicap.
Sanofi is committed to welcoming and integrating people with disabilities
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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