Regulatory Affairs Associate
B&S Group
- Location
- Vadodara, Gujarat, India
- Job type
- Full-time
About the role
Website:
bnsgroup.co.uk
Job details:
- Compilation of Module 1 for EU & UK submission.
- Preparation of SmPC, Patient leaflet (PL), Labelling (impack & outer) as per EU requirement and QRD guideline.
- Prepare/review clinical and non-clinical overviews (module 2.4 & 2.5), administrative and product information documents to obtain Marketing Authorisations.
- Prepare/review deficiency responses for clinical and non-clinical submission to obtain Marketing Authorisations.
- Prepare/review clinical and non-clinical national phase documents to obtain Marketing Authorisations.
- Provide clinical and non-clinical and BE study scientific literature support for the regulatory submissions as and when required.
- Regulatory strategy and contributing to development programmes for clinical and non-clinical overview.
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