Regulatory Affairs Specialist | Pharma (100% remote)

We are looking for a "Regulatory Affaris Specialist" for one of our clients in the Pharmaceutical Sector.

SKILLS :

• Bachelor's/Master's degrees or equivalent experience:
  
  

Scientific studies in biology, biochemistry, or analytical chemistry. "Equivalent Experience" may include completion of training as a technician, laboratory technician, or a comparable qualification, combined with several years of relevant professional experience

• Experience:
• Professional experience in the field of laboratory diagnostics (R&D, clinical trials, quality control) or in regulatory affairs or quality management.
• Professional experience in Regulatory, R&D, Quality, Opeartions, and/or Clinical Operations. Capable of managing moderately complex projects
• Good understanding of healthcare regulatory frameworks
• Basic understanding and application of regulatory strategy
• IT skills: Proficient in MS Office, databases, and document management systems
• Language skills: Good English skills (fluent in spoken and written English)
  

TASKS & RESPONSIBILITIES :

• Regulatory Document and Submission Compilation
  
  

Leads the preparation and management of regulatory dossiers and comprehensive global submission plans for moderately complex products or programs.

• Teamwork and Communication
  
  

Builds strong collaborative relationships, actively contributes to team efforts, communicates clearly and openly, listens effectively, and supports knowledge sharing and conflict resolution.

• External Interface Management Proactively partners with stakeholders to identify needs and solutions, builds strategic external relationships that influence Roche’s direction, and supports audits.
• Regulatory Knowledge and Strategy Develops solid understanding of healthcare regulatory frameworks (e.g., IVDR) and uses this knowledge to design regulatory strategies for products of simple to moderate complexity.
• Stakeholder Management and Influencing Effectively identifies and manages stakeholder relationships, ensuring timely and impactful communication to build trust and long-term collaboration.
• Decision Making Independently addresses daily tasks, identifies issues and solutions, and practices sound decision-making by gathering information, analyzing options, and acting without delay.
• Innovation and Problem Solving Drives innovation by generating new ideas, resolving issues collaboratively, and offering viable solutions while leveraging diverse perspectives.
• VAAC Leadership and Agility Embraces inclusive leadership, shows initiative, adapts to change, and demonstrates integrity, courage, and agility in identifying opportunities and contributing to team growth.
  
  

SCHEDULE :

• 08/09h -17/18h from Monday to Friday (flexible)
• 100% remote position
• Some business travel may be required
  
  

CONDITIONS :

• Salary package based on your profile.
• Permanent Contract.
• Flexible Retribution Program (medical insurance, public transport ticket and childcare check)
• Discounts on gym network (Wellhub)
• Learning & Development.
  
  

Our goal is that you are well in every way!