Regulatory Affairs Manager
4 days ago
We are seeking an experienced Regulatory Affairs Manager to join our team at TN Ireland. The successful candidate will be responsible for providing support to interpret the current, approved and planned clinical regulatory landscape.
About the Role:
- Contribute to the management of the regulatory submission form process, involving review of submitted documentation to global health authorities.
- Support cross-functional departments in understanding the current, approved regulatory landscape for all global CTAs.
- Participate in cross-functional meetings to help identify CMC regulatory issues related to submission documentation for clinical trials.
- Develop procedures and systems for enhanced tracking of global regulatory submission packages and approval status.
- Lead meetings and presentations on complex regulatory issues and create regulatory justifications.
- Maintain accurate records and communicate project status to management and partners.
- Collaborate with Regulatory Affairs, Clinical Drug Supply and Logistics, and Quality teams to ensure submissions meet requirements.
Key Responsibilities:
- Implement improvements to processes while managing scope changes during projects.
- Lead in matrix environments and collaborate with colleagues effectively.
- Communicate clearly and concisely in written and verbal reports.
- Manage multiple priorities and meet deadlines in a fast-paced environment.
Requirements:
- Minimum 5 years' experience in the life science industry with focus on biopharmaceutical manufacturing or regulatory activities.
- Bachelor's degree in Chemistry, Biology, or related field.
- Proven track record of leading or managing teams.
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