Project Opportunity for Regulatory Affairs Officer - 100% Remote, EU

Role : Regulatory Affairs Officer
Language : English
Location : EU, Remote

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 the 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.
· Cooperates with other organizational units and employees.

Requirements:
Qualification requirements for the job Education, exams and certificates
· 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.

If this sounds interesting kindly share your updated cv via E-mail.