What are the responsibilities and job description for the Regulatory Strategist – Vaccines position at Sanofi?
Job Title: Regulatory Strategist – Vaccines
Location: Swiftwater, PA/ Morristown, NJ
About the Job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
The team is involved in developing and executing regulatory strategies for vaccines in post marketing and in life cycle development stages to support and drive the growth of the Vaccines Global Business Unit (GBU).
The position is reporting to the PPH Global Regulatory Lead but may also support other Therapeutic areas based on business needs.
The Regulatory Strategist (RS) will mainly work on combination pediatric vaccines which drives Sanofi market’s growth and addresses an important public health need, but may also support other Therapeutic Areas as part of our agile organization.
As a key member of the Global Regulatory Team, the Regulatory Strategist is the strategic partner to contribute to the definition of the global regulatory strategy for assigned products, to enable and drive its execution in US, EU and worldwide countries, including Health Authority interactions.
We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.
Main Responsibilities:
Enables the Global Regulatory Lead (GRL) by providing quality regulatory input and position to internal business partners, including but not limited to the clinical development teams, commercial and Global Regulatory Team for assigned projects
Liaises with clinical, medical, commercial, supply functions, and other internal business stakeholders in partnership with the GRL to enable successful regulatory outcomes.
Contributes to the development of a harmonized, One Sanofi regulatory voice for providing strategic input through participation in appropriate governance committees and forums at the direction of the GRL. May represent Global Regulatory Team strategic position on behalf of the GRL at regulatory forums/committees at request of GRL.
Serves as regional/local point of contact with Health Authorities for vaccines in his/her remit. Contributes to the development of global Health Authorities interaction strategy, attends and may lead Health Authorities meetings, and leads the team through meeting preparations.
Identifies regulatory risks and proposes mitigations in collaboration with the GRL.
Contributes to the development of Global Regulatory Project Strategy (GRPS) and ensures alignment with the core product labeling for vaccines in his/her remit.
Participates in the development and monitoring of the global regulatory environment.
Leads submission team or regulatory sub team to ensure regulatory filings meet the project timelines for product launch.
May lead the IND/CTA submission strategy to ensure preparation timelines meet the project timelines for clinical trial initiation.
Contributes to content and reviews regulated documents (such as IB, PBRER, DSUR, RMP, etc).
Supports operational and compliance activities for assigned regulatory deliverables and develops regulatory submission planning, including submission tracking in the electronic document management system.
About You
Knowledge, Skills & Competencies:
Proactively contributes with curiosity and openness to diverse perspectives.
Understanding of target product profile and labeling, biological products. Vaccines is a plus.
Understanding of clinical development of drugs, biological products. Vaccines is a plus.
Demonstrates business acumen, leadership, influencing and negotiation skills.
Effective communication skills, specifically strong oral and written presentation skills.
Ability to work in electronic document management systems, e.g., Veeva Vault is a plus.
Demonstrated ability to handle multiple products/deliverables simultaneously.
Strong sensitivity for a multicultural/multinational environment.
Experience & Education:
BS/BA degree in a relevant scientific discipline required. Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) preferred.
At least 6 years or prior pharmaceutical/biotechnology industry experience, including at least 3 years of relevant Regulatory Affairs experience (regionally and/or global).
Significant track record of US, EU and International regulatory expertise required (demonstrated experience with preparation of NMAs, LCM activities, EU/US briefing documents) and negotiating with a national/regional HA preferred. Experience with China and Japan is a plus.
Digital training and understanding on Sanofi Digital Transformation (AI role)
Project leadership experience preferred.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
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.
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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
