Requirements: English
Company: EPM Scientific
Region: Saint-Mand , le-de-France
Main responsibilities
As a key member of the Global Regulatory Team, the Regulatory Strategist (RS) 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.
The Regulatory Strategist will also act as Digital Subject Matter Expert to support Sanofi Digital initiatives.
- 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
- Acts as Digital Subject Matter Expert in working groups to support Sanofi Digital initiatives
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
- Strong appetite for new technologies and digital trends, and ability to quickly adopt and master relevant digital tools
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 4 years or prior pharmaceutical/biotechnology industry experience, including at least 2 years of relevant Regulatory Affairs experience (regionally and/or global)
- Demonstrated experience with US, EU and International activities (preparation of NMAs, LCM activities, EU/US briefing documents). Experience with China and Japan is a plus
- Digital training and understanding on Sanofi Digital Transformation (AI role)
- Project leadership experience preferred