RA Project Manager
|Job Title:||RA Project Manager|
|Contact Name:||Alex Young|
|Job Published:||May 15, 2017 16:10|
Below is some key info -
Create a re-baselined Module 3 for a sterile injectable product which is registered in multiple global markets (EU, Asia Pacific, AU/NZ).
Priority 1: Work with a partner company in the Asia Pacific region to customise for local content and publishing requirements to enable a complete update of their marketing authorisation.
Priority 2: Roll out the updated dossier to all other global markets.
- Include changes already planned for this speciality in the EU
- Align with proposed updates being done in parallel for two other specialities within this Global MA (which includes Module 3, 4 and 5 updates)
- Gap analysis against current Asia Pacific registration to identify variations required to update filing
- Gap analysis against current EU registration to identify variations required to 're-baseline' in the EU
- Develop strategy to enable roll-out of global updated dossier
CMC authoring, Global Regulatory Strategy, Coordination of SMEs, Ability to work with CROs, Ability to work with global Marketing Authorisation Holders.
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