Associate Director Global Regulatory Affairs - Vaccine
Swiftwater, Pennsylvania, Toronto, Canada, Marcy-l'Étoile, France, Bridgewater, New Jersey, Chilly-Mazarin, France
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Our Sanofi Pasteur Swiftwater, PA site, where we both research and manufacture vaccines since 1897, has had a tremendous impact on global health and the quality of human life. Nestled among the Pocono Mountains in Swiftwater, Pennsylvania, Sanofi Pasteur is home to state-of-the-industry facilities—and a rich and unique history. Our Swiftwater campus is more than 500 acres, housing 44 buildings and encompassing more than one million square feet of building space. Many of our facilities, while bright and modern, still retain the rustic charm of the original stonework.
Health & Wellness
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.
At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.
Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.
"My family is everything to me. They are proud of the work I do, educating the community and ensuring that no Pompe patient is left behind."C. Richard Cioci Clinical Science Associate – Pompe Ontario East & Atlantic
"I am continually impressed at the dedication that Sanofi has to the patients for whom we provide solutions."Suncére Hernandez Area Business Manager, Multiple Sclerosis
"I give thanks to my powerhouse team for reminding me that I have a support system behind me, pushing me forward."Bob Shustack Head of Global Support Functions Finance, North America
Global Regulatory Team Leader - Global Regulatory Affairs - Sanofi Vaccines Global Business Unit.
The Global Regulatory Team Leader (GRTL) will report to the Global Regulatory Affairs Head of the Influenza and RSV Franchise and will support the life cycle management of the differentiated Influenza vaccines of the portfolio.
SUMMARY OF JOB PURSPOSE, MAJOR ACTIVITIES, KEY RESPONSIBILITIES
Lead the Global Regulatory Team (GRT)
The GRTL will lead the GRT, comprised of several RA members such as Regulatory CMC, Regulatory Labeling, RA Regions and Regulatory Operations.
The GRTL will work transversally to ensure a properly functional Global Regulatory Team. The GRTL facilitates the development and implementation of local regulatory strategy working with the regulatory platforms, regions and/or the countries. The GRTL provides the regulatory expertise necessary to develop global registration strategies for regional and local implementation.
The GRTL will lead some activities of products/projects managed by other GRTLs of the franchise as appropriate.
GRTL is the RA voice in cross-functional product/project teams
The GRTL is the main contact point between RA and non-RA stakeholders (e.g., Clinical, Global Medical Affairs, Pharmacovigilance, Non-Clinical, Commercial Franchise) for product related aspects.
The GRTL serves on cross-functional teams (Global project teams, Global Brand Teams, others) representing Global Regulatory Affairs for the product/project she/he is responsible and/or works with other GRTLs of the franchise who serve on cross-functional teams for the product/project activities he/she is in charge of, as appropriate.
The GRTL is responsible for presenting/defending the strategic information of the project/product regulatory strategies to key internal governance committees including but not limited to GRA Leadership team, R&D governance committee, Clinical Regulatory Strategic Forum, Product Safety Board, Vaccine Executive Committee, etc.
The GRTL is the GRA representative for Product Alert Teams/Crisis teams, as appropriate.
The GRTL will ensure timely communications of relevant topics to the business and up through GRA senior Management. The communication of any HA feedback should be interpreted and the impact on the project assessed
Lead the development of Regulatory strategy, its execution and prioritization
The GRTL will ensure the development of robust regulatory strategies, in collaboration with the GRT and other GRTLs of the franchise and is accountable for managing/coordinating the activities he/she is in charge of throughout the life cycle of the product/project. The GRTL is accountable for the execution of the global product activities, ensuring alignment on prioritization of the global regulatory product activities. The GRTL will develop the Global Submission Strategy (GSS), for his/her assigned products and will be accountable for developing and maintaining a global regulatory product strategy (GRPS) document.
The GRTL is responsible for prioritizing projects and activities with the GRT for lifecycle management activities (i.e. renewals, variations, new registration expansions) and with other GRTLs of the franchise as appropriate. The GRTL will work with the GRT to develop and maintain the core dossier/Product Reference File.
The GRTL will work with the labeling strategists and regional groups to ensure appropriate labeling content based on the clinical program and TPP. The GRTL will also work with the labeling strategist and regions to develop region specific labels.
The GRTL is accountable for the global regulatory strategy development of Health Authorities interactions
The GRTL may lead a transversal regulatory project where all product-related activities justify several GRTLs.
The GRTL is responsible for research and to analyse regulatory information and maintain current regulatory knowledge to keep abreast of regulatory procedures and changes
The GRTL ensure compliance with all internal and external requirements and procedures and may suggest improvement to operating policies/processes, as appropriate.
A robust regulatory strategy for products (in development or marketed), is critical for the success of the business and for the company to meet its goals.
In addition, regulatory strategy has an impact on the access time to market / pricing/ local recommendations.
GRTL role guarantee a worldwide regulatory strategy considered development needs and business needs. Interactions with Health Authorities is also key activity for the company in term of procedure management and about the image the company conveys
PhD, Pharm D or DVM or MSc in Biology, Life Science, or related field of study; at least 3 to 5 years of prior Regulatory Affairs experience (global development, US, EU, International)
Demonstrated knowledge of microbiology, immunology, virology or bacteriology.
Proven record of successfully managed regulatory activities in regulatory disciplines i.e. variations, line extensions, extension of indication, pediatric development, clinical trial management, registrations
Experience working on Global Project Teams preferred
Languages: English fluent required (Other optional)
KNOWLEDGE, SKILLS AND EXPERIENCE
Strategic skills including the ability to help complex decisions to be made and ability to support difficult positions.
Understanding of the Global (including US, EU, International) and pharmaceutical marketplace
Interaction/negotiation skills with regulatory authorities (e.g. FDA, EMA, Health Canada, PMDA, Chinese HA etc.)
Good knowledge and understanding of scientific subject matter (including medical) as well as evolving regulatory policy and guidance
Excellent coordination skills including planning, organizing and ability to motivate and lead others.
Ability to work well within cross-functional teams and excellent transversal collaboration skills.
Can demonstrate solid oral communication, presentation and writing skills
Develops collaborative relationships to facilitate the accomplishment of work goals
Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities
Ability to identify risks and manage risks through mitigation and communication.
Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans
Can build networks to obtain cooperation without relying on authority
Strong sensitivity for a multicultural/multinational environment
Unquestionable ethics, professional integrity, and personal values consistent with the Sanofi values
At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.
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.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities
According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.
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.