Regulatory Strategist with Digital capabilities

JR France; Paris; Sur place; EUR 70 000 - 100 000; Plein temps

Résumé du poste

A leading company in the pharmaceutical sector seeks a Regulatory Strategist in Paris to spearhead global regulatory strategies and support digital initiatives. The ideal candidate will possess strong leadership skills, a proven track record in regulatory affairs, and an understanding of digital transformation in regulatory frameworks. This role combines strategic oversight with collaboration across internal teams, making it key to ensuring product compliance and success in international markets.

Qualifications

• Minimum 4 years experience in pharmaceutical/biotech industry.
• At least 2 years in Regulatory Affairs required.
• Experience with US, EU, and international regulatory processes essential.

Responsabilités

• Define and execute global regulatory strategies for products.
• Collaborate with internal teams to ensure regulatory success.
• Act as a contact point with Health Authorities.

Connaissances

Leadership

Communication

Negotiation

Digital Skills

Formation

BS/BA in relevant scientific discipline

Advanced degrees (PharmD, PhD, MD, DVM, MSc)

Outils

Veeva Vault

Description du poste

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Regulatory Strategist with Digital capabilities, paris

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Client:

EPM Scientific

Location:

paris, France

Job Category:

Other

-

EU work permit required:

Yes

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Job Reference:

557346747247388262432760

Job Views:

2

Posted:

29.05.2025

Expiry Date:

13.07.2025

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Job Description:

Main Responsibilities

As a key member of the Global Regulatory Team, the Regulatory Strategist (RS) is a strategic partner in defining and executing global regulatory strategies for assigned products, ensuring successful implementation across US, EU, and worldwide markets, including Health Authority interactions.

The Regulatory Strategist will also act as a Digital Subject Matter Expert to support digital initiatives.

• Enables the Global Regulatory Lead (GRL) by providing quality regulatory input and guidance to internal stakeholders, including clinical development, commercial teams, and the Global Regulatory Team for assigned projects.
• Collaborates with clinical, medical, commercial, and supply teams to drive regulatory success in partnership with the GRL.
• Contributes to regulatory strategy development by participating in governance committees and forums. May represent the Global Regulatory Team's strategic position at regulatory forums/committees upon GRL request.
• Serves as a regional/local point of contact with Health Authorities for vaccines in their remit. Supports global Health Authority interaction strategies, attends and may lead Health Authority meetings, and guides the team through preparation phases.
• Identifies regulatory risks and proposes mitigation strategies alongside the GRL.
• Helps shape the Global Regulatory Project Strategy (GRPS) and ensures alignment with core product labeling for vaccines.
• Monitors and contributes to the evolution of global regulatory frameworks.
• Leads submission teams or regulatory sub-teams to ensure filings align with project timelines for product launches.
• May oversee IND/CTA submission strategies to meet clinical trial initiation timelines.
• Reviews and contributes to regulated documents (e.g., IB, PBRER, DSUR, RMP).
• Supports operational and compliance activities for regulatory deliverables, including submission planning and tracking within electronic document management systems.
• Acts as a Digital Subject Matter Expert in working groups focused on digital innovation.

About You

• Proactively contributes with curiosity and openness to diverse perspectives.
• Understanding of target product profiles, labeling, and biological product development. Experience with vaccines is a plus.
• Demonstrates business acumen, leadership, influence, and negotiation skills.
• Strong oral and written communication skills, with effective presentation abilities.
• Familiarity with electronic document management systems (e.g., Veeva Vault is a plus).
• Capable of handling multiple products and deliverables simultaneously.
• Strong cultural awareness and ability to navigate multinational environments.
• Passion for new technologies and digital trends, with the ability to quickly master relevant digital tools.

Experience & Education

• BS/BA degree in a relevant scientific discipline required. Advanced degrees (PharmD, PhD, MD, DVM, or MSc in Biology/Life Sciences) preferred.
• Minimum 4 years of pharmaceutical/biotechnology industry experience, including at least 2 years in Regulatory Affairs (regional and/or global).
• Proven experience with US, EU, and international regulatory processes (e.g., NMAs, LCM activities, briefing documents). Experience with China and Japan is a plus.
• Digital training and understanding of digital transformation strategies within regulatory frameworks.
• Project leadership experience preferred.