This role is pivotal in ensuring the quality and compliance of medical devices and drug registration.
We are seeking a highly skilled professional to join our team as a Regulatory Affairs Manager, reporting directly to the Head of QARA. In this capacity, you will play a critical role in developing and executing regulatory plans aligned with business strategy for complex projects.
Your responsibilities will include:
- Developing and implementing regulatory plans for new products and maintaining regulatory files for existing marketed products
- Identifying and prioritizing key areas of risk, and developing mitigation plans to ensure compliance
- Establishing effective communication channels within RA, with global Marketing, and other functions at project level
- Ensuring Registration strategy and deliverables align with project teams and business objectives
- Leading regulatory activities related to their portfolio of products
- Preparing, reviewing, and approving labeling and J-CTD based on global dossier in cooperation with PV/MDS
- Representing or leading the RA function on assigned cross-functional project teams
- Maintaining applicable regulatory documentation and proposing solutions for improvement
As a Regulatory Affairs Manager, you will be responsible for ensuring that our medical devices and drug registration meet the highest standards of quality and compliance. If you are a detail-oriented and strategic thinker with excellent communication skills, we encourage you to apply for this exciting opportunity.
Estimated Salary: $120,000 - $180,000 per year
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Minato Baxter Full timeThis role is pivotal in ensuring the quality and compliance of medical devices and drug registration. · We are seeking a highly skilled professional to join our team as a Regulatory Affairs Manager, reporting directly to the Head of QARA. In this capacity, you will play a critica ...
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