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Regulatory Affairs Expert

1 tydzień temu


Poznań, Greater Poland TN Poland Pełny etat
Job Description

We are seeking a Senior Regulatory Specialist to join our Polish Hub. This role is responsible for coordinating and developing the CTA/IND lifecycle strategy, ensuring timely content delivery and compliance with GSK policy and procedures.

The successful candidate will be accountable for overall work plans and accountable to individual GRLs/TGs for study submission planning and delivery status. They will ensure independent communication with internal GSK staff to achieve assigned goals and deliver high-quality work on time.

This role requires a strong understanding of regulatory affairs in the R&D, pharmaceutical industry or clinical trials. The ideal candidate will have a broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.

The successful candidate will possess excellent organizational skills, attention to detail, and commitment to delivering high-quality output. They will also have the ability to lead in a matrix environment, ensure delivery of objectives across cross-functional teams, and work effectively in multiple IT systems.