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Regulatory Affairs Specialist
Il y a 3 mois
Regulatory Affairs Officer / Linguistic Review Coordinator M/F - 025
We are seeking a dedicated Regulatory Affairs Officer / Linguistic Review Coordinator to oversee and facilitate the Linguistic Review (LR) for centralized products associated with one of our prominent clients. This role is crucial for ensuring compliance and quality in our regulatory processes.
Key Responsibilities:
- Lead and coordinate the Labelling team responsible for the Linguistic Review of products.
- Engage in regulatory activities pertinent to the Linguistic Review process for Centralized Procedure (CP) medicinal products, including linguistic assessments for new Marketing Authorization Applications (MAAs) and post-licensing modifications.
- Manage relationships with translation partners and oversee the translation tools to streamline the review and coordination of Linguistic Review processes with both internal and external stakeholders.
- Provide continuous support to project teams, ensuring that all project-related concerns are addressed and planned for effectively.
Educational Requirements:
- A minimum of a Bachelor's Degree in Life Sciences is required, with a preference for candidates holding a Pharmacy Degree (PharmD).
Professional Experience:
- A background of at least 1-2 years in Regulatory Labelling Operations within a Pharmaceutical Company or Service Provider is essential.
Required Skills:
Hard/Technical Skills:
- Strong understanding of regulatory labelling procedures.
- Experience in Project Coordination and Management.
- Previous experience in Line Management is advantageous.
- Proficient IT skills and the capability to adapt to relevant software.
- Solid knowledge of Microsoft Suite applications.
Soft Skills:
- Proficiency in English is mandatory, with exceptional grammar skills in both written and verbal communication.
- Outstanding organizational and interpersonal abilities.
- Excellent oral and written communication skills, particularly in client-facing situations.
- Ability to work collaboratively within a team as well as independently.
- Competence in prioritizing multiple tasks and managing workloads effectively.
- Capability to meet tight deadlines while maintaining high-quality standards.
- A strong sense of personal responsibility for delivering superior work.
