Job Title : Senior Executive Regulatory
Job Description :
- Publishing and maintaining log of regulatory communications by region and product.
- Peparation of CTD modules as per e-CTD norms.
- Publishing regulatory subission documents like IND, IPD, MAA, NDA, DMF in electronic submission form.
- Preparation of documents for regulatory advices in US, EU and Japan.
- Review of CMC documets from cross funcional teams and ensure regulatory compliance.
- Maintenance and submission of Electronic submission software.
- Maintenance of product life cycle documents by Country and product.
Experience Required : 2-3 years
CLICK HERE FOR MORE INFO
0 comments:
Post a Comment