
Compliance Officer Regulatory Affairs Specialist
2 days ago
Job Summary
Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team.
The successful candidate will be responsible for the preparation and review of regulatory documents, including dossiers, briefings books, and labeling.
They will also coordinate with internal stakeholders and external counterparts to review regulatory documents and proposals.
The ideal candidate will have excellent communication and problem-solving skills, as well as the ability to work effectively in a team environment.
Key Responsibilities:
- Preparation and review of regulatory documents, including dossiers, briefings books, and labeling.
- Coordination with internal stakeholders and external counterparts to review regulatory documents and proposals.
- Identification of open issues at product development, ANDA filing, and deficiency responses.
- Support to commercial launch team w.r.t review progress and evaluate changes proposed for commercial batches.
Requirements
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