Regulatory Strategist Senior Manager / Associate Director Vaccines - #9754671
Jobs for Humanity
Company Name: Sanofi
Job title: Regulatory Strategist (RS)
Grade: (only for internal Job description)
Hiring Manager: Global Regulatory Lead
Location: multiple locations
% Remote working and % of travel expected: NA
Job type: Permanent, Full time
Please note that this is a general description of roles and competencies, and some flexibility may be required.
About the job
We are a team that develops regulatory product strategies for the medical field. We lead regulatory efforts during the development and marketing stages of drug products.
As a key member of the Global Regulatory Team (GRT), and working closely with the Global Regulatory Lead (GRL), the Regulatory Strategist provides regulatory expertise to define global regulatory strategies and ensure their execution, including interactions with Health Authorities.
The Regulatory Strategist provides regulatory guidance to the GRT and cross-functional teams, working flexibly across regions to achieve business objectives.
The role involves collaborating with internal partners, such as clinical development teams and commercial teams, to provide regulatory input and ensure successful regulatory outcomes.
The Regulatory Strategist contributes to the development of a unified regulatory voice within the company through participation in appropriate committees and forums.
They may also serve as a regional/local regulatory lead and point of contact with Health Authorities for specific projects/products.
The Regulatory Strategist identifies regulatory risks and proposes mitigations in collaboration with the GRL and cross-functional teams.
The role contributes to the development of Global Regulatory Project Strategy (GRPS) and ensures alignment with product labeling.
They also participate in the development and monitoring of global regulatory environment, standards, and processes related to drug and biologics regulations.
Other responsibilities include leading submission teams, developing Health Authority engagement plans, and supporting operational and compliance activities.
Knowledge, Skills & Competencies: (Minimum required)
Proactively contribute with curiosity and openness to diverse perspectives.
Emerging understanding of clinical development of drugs and/or novel biologics products.
Demonstrates business acumen, leadership, influencing and negotiation skills.
Effective communication skills, specifically strong oral and written presentation skills preferred.
Ability to work with electronic document management systems, e.g., Veeva vault is a plus.
Demonstrated ability to handle multiple projects simultaneously is preferred.
Strong sensitivity for working in a multicultural/multinational environment.
Experience & Education: (Minimum required)
Minimum of a Bachelor's degree in a relevant scientific discipline or Master's degree in Biology, Life Science, or related field with at least 5 years of relevant pharmaceutical/biotechnology industry experience, including at least 3 years of relevant Regulatory Affairs experience. Alternatively, an advanced degree (PharmD, PhD, MD, or DVM) with at least 2 years of regulatory or relevant pharmaceutical/biotechnology industry experience is required.
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Learn more about our Diversity, Equity, and Inclusion actions at sanofi.com and watch our ALL IN video.
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, liability for military status, domestic violence victim status, atypical cellular or blood trait, genetic information (including 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 recognize that true progress comes from leading with inclusion and fostering a workplace where differences can thrive and be leveraged to empower our colleagues, patients, and customers. We respect and celebrate the diversity of our people, their backgrounds, and experiences, and provide equal opportunity for all.