We expect the Manager, Regulatory Affairs CMC to join a growing team and provide support to interpret the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process.
In this role, a typical day might include the following :
- Contributes to the management of the regulatory submission form process, which involves the review of submitted documentation to global health authorities to support the release of lots to clinical trials.
- 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.
Ensure appropriate communication between IOPS and global development in a timely manner.
- Participates in the development of procedures and systems for enhanced tracking of global regulatory submission packages and approval status.
- Lead meetings and presentation on more complex regulatory issues and participates in creating regulatory justifications
- Keeps management and all partners up to date of assessments, overall strategy, and project status.
- Contribute to training programs, metrics, and invoice approvals
- May act as a submission compliance liaison with other areas of Regulatory Affairs, Regulatory Submission Management, Clinical Drug Supply and Logistics, and Quality to ensure the submissions appropriately support the release of IP
This role might be for you if :
- You have a strong understanding of quality principals in a regulated manufacturing environment.
- You bring strong communication and program management skills
- You can implement improvements to processes while having scope changes occur during the project.
- You are able to lead matrix environments and collaborate easily with colleagues
To be considered for the opportunity, we expect you to have at 5 years of experience in the life science industry with a focus in biopharmaceutical manufacturing or regulatory or compliance related activities with a Bachelor's degree in Chemistry, Bio or related field.
We also expect individuals to have managed or lead teams for 2 years.
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