Regulatory Affairs-Manager
ZIM LABORATORIES LIMITED
Date: 1 week ago
City: Nagpur, Maharashtra
Contract type: Full time
JOB Responsibility
- Preparation, review & submission of ectd/ctd dossier as per requirement of regulated market authorities i.e. Europe, Brazil, Canada, RoW for pharmaceutical products
- Preparation, review & submission of dossier as per DCGI requirement for submission in CDSCO
- Preparation, review & submission of techpack as per requirement of regulated market authorities i.e. Europe, Brazil, Canada, RoW for Nutraceutical products
- Query response raised by (MoH/Customer) to EU, Regulated, and Emerging & ROW of Pharma & Nutra products
- Documents review – QQF, Change control, specifications, Commercial specifications, artworks
- Process Validation Protocols & Report, Hold time study protocol & report, NDMA reports, Photo stability reports, Elemental reports, Risk assessment, Out of Specification.
- Co-ordination with external & internal clients.
- Updation and maintenance of database of dossier status.
- Fulfil requirement for site registration and GMP clearance/approvals
How to apply
To apply for this job you need to authorize on our website. If you don't have an account yet, please register.
Post a resumeSimilar jobs
Senior Executive - Debt Management Services - The Wheels - 2W/3W
Bajaj Finserv,
Nagpur, Maharashtra
5 days ago
Location Name: NAGPUR AFJob Purpose“This position is open with Bajaj Finance ltd.”First link of management between the executors i.e. field staff and management. An effective communicator with exceptional relationship management skills with ability to relate to people at all levels of business and management. Delivery of business AOP objectives for the assigned geography.Duties And ResponsibilitiesPRINCIPAL ACCOUNTABILITIES(Accountabilities associated with the job) ...
Field Sales Executive
HERD Medical Foundation Pvt Ltd,
Nagpur, Maharashtra
6 days ago
Herd Medical Foundation, a distinguished entity within the Hospitality industry, is currently seeking a dynamic and results-driven Field Sales Executive to join our dedicated team. In this pivotal role, you will be at the forefront of expanding our market presence, fostering strong relationships with potential clients, and ultimately driving our mission to provide unparalleled service in the medical hospitality sector....
Solution Designer
Tech Mahindra,
Nagpur, Maharashtra
1 week ago
Job SummaryTO lead AND guide development AND design activities, ensuring delivery OF solutions against defined requirements. Review OTHERS system design to ensure selection of appropriate technology, efficient use of resources, and integration of multiple systems and technology. Ensure that the system architecture balances functional, service quality and systems management requirements. Ensure delivery of solution against the defined requirements. Identify and...
