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, Operations, 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.
* Learning & Development.
Our goal is that you are well in every way