
Regulatory Compliance Expert
1 day ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and providing strategic inputs to support the development and launch of new products.
The successful candidate will have a strong background in pharmaceuticals and experience in preparing and reviewing regulatory documents, including US ANDAs, 505(b)(2), EU and Canada dossiers. They will also be responsible for coordinating with internal stakeholders and external counterparts to review regulatory documents and proposals.
In this role, you will provide support to commercial launch teams by reviewing progress and evaluating changes proposed for commercial batches. You will also ensure that eCTD publications and dossiers are filed according to regulatory guidelines.
Key Responsibilities:
- Prepare and review regulatory documents, including US ANDAs, 505(b)(2), EU and Canada dossiers
- Coordinate with internal stakeholders and external counterparts to review regulatory documents and proposals
- Provide support to commercial launch teams by reviewing progress and evaluating changes proposed for commercial batches
- Evaluate stability protocols, analytical methods, and specifications for commercial batches
Qualifications:
To be considered for this role, you should have a M.Pharm, M.Sc or PhD in a relevant field, such as pharmaceutical sciences, biochemistry, or chemistry. You should also have excellent communication and project management skills, with the ability to work effectively in a team environment.
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