Emcure Pharmaceuticals Released Job Openings On 09/06/2022.Emcure Pharmaceuticals is a fast growing fully integrated Indian pharmaceutical company with global presence engaged in developing, manufacturing and marketing a broad range of pharmaceutical products globally. Our core strength lies in developing and manufacturing differentiated pharmaceutical products in-house, which we commercialize through our marketing infrastructure across geographies and relationships with multi-national pharmaceutical companies.
Vacancy Details:
Emcure Pharmaceuticals Limited Recruiting M.Pharm Candidates with 10-15+Years Experience for Senior Manager/ AGM Regulatory Affairs- Europe Market Position.Complete Details for the Senior Manager/ AGM Regulatory Affairs- Europe Market as follows.
Important Details :
- Location : Pune
- No of Vacancies:01
- Details of Salary:NA
- Opening date for online Application:09/06/2022
- 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
- Strong experience in Regulatory Affairs for Europe market.
- To build regulatory strategy for submission of initial MAA for EU (DCP/MRP/NP/CP), evaluation of changes and maintenance of product life-cycle for different dosage forms.
- Compilation of dossiers in CTD, eCTD & national formats for Europe
- Compilation and submission of queries and variations.
- Interaction with UK & EU Offices and sometimes with HAs for submission related queries and scientific advise.
- Regulatory compliance with Front offices and with Plant.
- Review of documents, artworks
- Review of change controls
- Gap analysis for new product filing
- Maintaining product Life cycle
- Liaise with all cross functional departments for evaluation/approval of change proposal/deviations/escalation and their execution.
- Internal guidance document preparation.
- Work allocation to subordinates with tracking and review of tasks.
- People management- Responsible for training and development of team.
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