What are the responsibilities and job description for the Regulatory Affairs Project Manager position at EPM Scientific - Phaidon International?
The Company :
In order to make an application, simply read through the following job description and make sure to attach relevant documents.
My client is a purpose-driven organisation focused on pioneering and commercialising novel health care solutions for individuals with unmet medical needs. With over 30 years of research in their clinical pipeline, they provide patients with new treatment options and extend their expertise into broader health care applications. As a rapidly growing company, they seek candidates who share their entrepreneurial spirit and are excited to contribute to a dynamic, international team working toward impactful results.
The Role :
The Regulatory Affairs Project Manager will be responsible for staying current with regulatory changes in key markets, preparing documentation for New Drug Applications, and managing post-marketing requirements, including market access and IRB submissions. They will also oversee regulatory submissions for clinical programs, orphan drug designation, and labelling / packaging material supply. As part of our client's fast-growing, dynamic international team, this candidate will help deliver impactful health care innovations while working closely with leadership to meet deadlines.
Key Responsibilities :
- Regulatory
Assist in the development of the ongoing global regulatory strategy
Prepare and / or collate all documentation to support clinical trial applications
Obtain approvals on labelling text and design by competent authorities
Qualifications :
J-18808-Ljbffr
