Job Description
Job Responsibilities
- Regulatory Strategy Development
- Identifying the most efficient regulatory pathway for drug approval.
- Preparing a comprehensive plan to comply with international regulatory requirements.
- Advising on timelines, documentation, and submission requirements.
- Understanding the nuances of different regulatory bodies is crucial for developing strategies that minimize delays and maximize approval success.
- Preparation and Submission of Regulatory Documents
- A core responsibility of DRA professionals is preparing, reviewing, and submitting regulatory documents to authorities.
- Attention to detail and knowledge of submission platforms, such as CTD (Common Technical Document), are essential.
- Liaising with Regulatory Authorities
- Responding to queries and requests for additional information.
- Attending meetings with regulatory agencies to discuss the drug development p...
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