Regulatory Affairs Manager (m/f/d) Fulltime-hybrid Romania

Details

Beschreibung

Tasks

•Compilation of maintenance dossiers with the help of the electronic systems (DMS/Publishing)
•Participates in decisions to optimize internal processes within the team
•Preparation, checking, revising and maintenance of all regulatory documents required to be prepared within the GRA Department
•Manage and review of labeling and/or promotional materials for submission to the Regulatory Agencies. Engages in other labeling-related responsibilities, i.e. dummy RMS P.I. maintenance
•Adheres to all applicable procedures, GMPs, company policies and any other quality or regulatory requirements

• Responsible for the efficient use of company resources
•Ensures confidentiality of information is maintained
•Respects the rules of operation and organization
•Fulfils other tasks appropriate to their professional background, assigned by the Team Leader
•Responsible for enforcement of safety and health rules at work and also in terms of emergency situations management and is responsible for implementing these measures.
•Participates in professional training programs developed or attended by the Global Regulatory Affairs department.

Qualification

•Bachelor’s or advanced degree in a relevant field.
•Proven experience in regulatory affairs within the pharmaceutical industry.
•Knowledge of regulatory requirements in the EEA and Switzerland.
•Other qualification, expertise and experience necessary for the job
•Strong project management and communication skills.
•Commitment to confidentiality and compliance.
•Effective negotiation and interpersonal skills.

General Information’s

Project start: asap/01.11.2024
Project duration: 4 Months
Project end: 11.01.2025
Location: Timisoara (Romania)
Capacity: 5days/week
Remote: tbd
On-site: tbd

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