Regulatory Affairs Consultant

Consultants in Science; Épalinges; Remote; CHF 120’000 - 160’000; Vollzeit

Zusammenfassung

A leading biotech company is seeking a Regulatory Affairs Consultant to drive regulatory strategy as they approach critical milestones. This flexible, remote-friendly role requires extensive experience with FDA and EMA submissions, providing a unique opportunity to influence early-stage development in a dynamic start-up environment.

Leistungen

Flexible, remote-friendly role

Potential for long-term collaboration

Qualifikationen

• 8+ years of Regulatory Affairs experience in biotech/pharma.
• Proven success with FDA and EMA submissions.
• Ability to thrive in a dynamic start-up environment.

Aufgaben

• Shaping regulatory strategy for preclinical and clinical development.
• Preparing for IND/IMPD submissions.
• Leading health authority interactions (FDA, EMA).

Kenntnisse

Regulatory Affairs

Biologics Development

Strategic Mindset

FDA Submissions

EMA Submissions

Jobbeschreibung

• Jo
• Jun 2
• 1 min read
  
  

The Company

We’re partnering with an early-stage biotech company developing a novel therapeutic candidate. As they approach critical preclinical and regulatory milestones, they are seeking a seasoned Regulatory Affairs Consultant to shape and drive their regulatory strategy across both the US and EU markets.

The role

You’ll serve as the company’s go-to regulatory expert, providing high-level guidance and hands-on support. This includes:

• Shaping regulatory strategy for preclinical and early clinical development
• Preparing for IND/IMPD submissions
• Leading health authority interactions (FDA, EMA)
• Conducting regulatory gap analyses and reviewing the Target Product Profile (TPP)
• Supporting CMC-related documentation and regulatory planning
  
  

What We're Looking For

• 8+ years of Regulatory Affairs experience in biotech/pharma
• Proven success with FDA and EMA submissions
• Experience in biologics development and submissions (IND/IMPD, Orphan Designation, Scientific Advice, etc.)
• Ability to thrive in a dynamic start-up environment
• Strategic mindset with flexibility to scale involvement as needs evolve
• Must be resident in Switzerland and authorized to work in Switzerland
  
  

Why Apply?

• Join a cutting-edge biotech with real potential
• Influence early-stage development strategy
• Flexible, remote-friendly role with minimal travel (monthly in-person meetings at Biopôle)
• Potential for long-term collaboration as the project grows
  
  

To apply please email your CV to [e-mail]

Tags

• regulatory affairs
• Consultants
• Vacancies