Description
Regulatory Compliance ManagerHomebased Role
This is an opportunity for a regulatory affairs specialist to join a global service provider within the pharmaceutical industry. If you are interested in working for a company that put their customers in the forefront of their organisation then please read below to see if you would qualify for this position.
Experience Required:
- CRO
- High volume of CMC experience
- Pre-clinical IMPD requirements
- Gap Analysis
- Submission experience
- Regulatory intelligence
- Submissions strategy, assess risks and identify potential solutions
- Liaise with CRA in regards to collecting documents
- Coordinate the preparation of IMP country label and QC them
- Coordinate translations of protocol/IB/protocol synopsis/ICF and other patient documents and coordinate the internal review of such documents
- Gap analysis and Medical Device US IDE filing/strategic expertise is essential.
- Review protocol, master ICF, IMPD
- Coordinate the customization of country ICFs and QC them
For an additional conversation regarding the role and the company please do contact me on alternatively you can email me on L.khan at realstaffing.com