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15 hours ago
We are seeking an experienced Regulatory Affairs professional to join our team.
The ideal candidate will have extensive experience in managing regulatory affairs for pharmaceutical products, including dossier compilation, submission, and query response. This role requires strong leadership skills, attention to detail, and excellent communication abilities.
- Key Responsibilities:
- Compile dossiers for multiple markets, including the US, EU, Australia, Canada, and Israel.
- Manage activities related to dossier submission, including timeline management and query response.
- Assign projects to regulatory associates and oversee the team for all regulatory submission activities.
- Develop and maintain relationships with stakeholders to ensure timely receipt of documents for dossier compilation.
- Provide single-point contacts for all regulatory submission activities.
To be successful in this role, you must have:
- Strong knowledge of regulatory affairs principles and practices.
- Experience in managing regulatory submissions and dossier compilations.
- Excellent leadership and communication skills.
- Able to work effectively in a fast-paced environment with tight deadlines.
- Familiarity with pharmaceutical regulations and guidelines.
-
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