Macleods Pharmaceuticals Released Job Openings On 08/08/2022.Macleods, India Fastest growing pharmaceutical company, with a strong R&D and own Bio-equivalence centre, manufacturing sites approved by USFDA & WHO Geneva, ranked among the top pharmaceutical companies with a strength of more than 10,000 employees, presently operating in more than 50 countries worldwide..
Vacancy Details:
Macleods Pharmaceuticals Recruiting B.Pharma,M.Pharma Graduates with 09-11+ Years of Experience for Regulatory Affairs Manager- Europe Market Position.Complete Details for the Regulatory Affairs Manager- Europe Market as follows.
Important Details :
- Location : Mumbai (All Areas)
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary: NA
- Opening date for online Application:08/08/2022
- Mode of application :Online
- How To Apply:At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
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Job Description/Skills Required
- 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.
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