Spclst, Regulatory Affairs
il y a 2 semaines
Major Functions & Responsibility:
- For assigned products ensures high quality labelling translation and artwork management.
- Supports the agency interactions to ensure a seamless submission, assessment, and quick approval of the CTAs, according to the new EU CT Regulation, in cooperation with RAE Liaison, and other internal stakeholders.
- For assigned products and tasks, stays updated on relevant EU and local regulations and guidelines.
- Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
- Maintains a positive relationship with internal and external regulatory contacts. GRACS on subregional, regional and global level, MMD, EUQPPV and GSC&PV are the main contact points within the company. External contacts are regulatory authorities, as well as other key players in the regulatory environment.
- B.Sc. degree in pharmacy or other life science or equivalent.
- Preferable prior experience in the pharmaceutical industry, in a regulatory, medical or laboratory position.
- Ability to communicate well verbally and in writing, good organizational and planning skills. Attention to detail and flexibility to successfully handle conflicting time pressures and prioritize work, as well as critical thinking. Ability to work both individually and as part of a team, and have creative approaches to solve problems.
- Native fluency in Dutch or French, with proficiency in English.
Search Firm Representatives Please Read Carefully
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Requisition ID:
R227274
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