Contract

Regulatory Affairs Associate (Medior)

SalaryCompetitive
LocationBelgium
SectorPharmaceuticals & Biotechnology

Description

The primary responsibilities of this position include the following.  The incumbent may perform other duties, as assigned:

-  Directly communicate with Country RA team members to develop global regulatory project plans, including a detailed list of submission deliverables, dependencies, approval timing and cost.

- Compile regulatory documentation in support of medical device and drug submissions in accordance with local regulatory requirements.

- Create / maintain overall schedule for global registration activities, and communicate accomplishments and risks to global project team.

- Coordinate responses to regulatory authority queries with strict deadlines.

- Support Country RA to maintain and update existing regulatory authorizations

- Prepare / update product labeling (i.e., create red-lines, route documents through review / approval process).

To perform this job successfully, an individual must possess the following:

•    Excellent written and verbal communication skills

•    Ability to manage complex / multiple projects and deadlines effectively

•    Ability to identify risks and escalate when necessary

•    Negotiation skills

•    Past experience supporting global Pharmaceutical registrations; medical device global regulatory experience is advantageous

•    Scientific knowledge

•    Technical system skills (e.g. word processing, spreadsheets, Microsoft Project, databases, online research, SharePoint)

Education:

Bachelor’s degree or country equivalent in engineering, chemistry, or related scientific discipline with a minimum of 5 years regulatory or equivalent experience within a pharmaceutical company or similar organization. 

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