Sanofi Group Senior Director, Global Regulatory Therapeutic Lead in 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:
is accountable for the development of the global regulatory strategies for projects/products within the assigned portfolio, in close collaboration with affiliates.
is 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 accountable of the follow up of the implementation of the global strategy with RA affiliates.
ensures the one GRA voice, set-up and run GRA team meetings as needed
ensures timely execution of the GRPS milestones for the development projects as per Blue print
participates in the organization of scientific advice meeting with the Health Authorities
participates and validates the promotional and non-promotional programs for Global brands
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.
manages the interactions as appropriate with the Countries GRA to ensure compliance with local requirements
works in compliance with Sanofi Quality Documents (QDs)
sets-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
contributes 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
Competencies for success:
capacity to Empower teams to face challenges, make decisions and take action
capacity to Encourage collaboration and communication within and beyond the team
Capacity to Lead teams
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.
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
Organizational savvy; be able to work in a highly matrix structure
“Think out of the box” mindset
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
EDUCATION : :
- Minimum MS; Pharm D, MD, PhD or equivalent preferred
Sanofi US Services, 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 are foundational to how we operate and are embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. We recognize that 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 employees, patients and customers.
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