Macleods Pharmaceuticals Recruitment 2022 . Macleods Pharmaceuticals Notification full details below.Intrested and eligible candidates Apply Online.Macleods Pharmaceuticals, India’s fastest growing company was established in 1986. Ranked amongst the top 10 pharma companies with a strength of 20000 employees, operating in 140+ countries. Our bioequivalence centre was established in 2005 .
Vacancy details:
- Post Name: Regulatory Affairs Manager- Europe Market
- Qualification: B.Pharma in Any Specialization ,M.Pharma in Any Specialization
- Experienced:09 – 14 years
Job Description: Macleods Pharmaceuticals Hiring For Boiler Operator !
Important Details :
- Location: Mumbai (All Areas)
- Post of date: 08/08/2022
- Selection Process: The selection will be on the basis of Interview.
Roles and ResponsibilB.Pharma in Any Specialization ,M.Pharma in Any Specializationes
1. Preparation and submission of registration dossier, renewal application and variation
application for EU submission.
2. Preparation of respective CTD sections and submission of final query response to agency
3. Preparation and submission of documents for national phase to respective European
regulatory agency to receive national approval
4 . To upload documents in national portal for respective European regulatory agency
5. Co-ordination with different department for getting required data for compilation of
registration dossier, renewal application and variation
6. Review of the mock ups for all regulatory submissions and commercial supplies
7. Maintenance of internal database
8. Co-ordination with consultant for national submissions, product information translation,
readability testing etc
9. Review and approval of change control and deviations
10. Coordination with customer and consultant in order to timely submissions of new
applications, query responses, variations and renewals
11. Review of variation packages.
