Actide International
Location
Vadodara | India
Job description
Job Description
-Compilation and submission of eCTD dossier for new product application (ANDA/EU-MA)/Post approval submission to the regulatory authority (specifically EU/US)
-Hand on experience in preparation of CTD section as per regulatory requirements of different region
-Having experience in preparation of query response and PAS, CBE and annual report.
-Have ability to co-ordinate with cross functional team
-Having experience for Drug listing and annual updates
-Having ability to review documents as per current regulatory guidelines.
- Have experience of compilation of Labelling section of US ANDA/EU MA
-Preparation and review of artwork related to ANDA in line with innovator product
-Maintain product life cycle for Labelling requirement inline with RLD updates
-Submission of labelling SPL through software as per regulatory requirements
-Have hand Ons experience for handling of E-CTD software
Regulatory Affair,RA
Designation: Regulatory Affairs - Pharma
Vacancies: 1
Experience: 10.0 Year(s) - 15.0 Year(s)
Job tags
Salary
Rs 10 - 15 lakhs p.a.
