Company: Alkem Laboratories Ltd
Post: Research Associate Regulatory Affairs - EU Market
Experience: 2-3 yrs
Location: Taloja Navi-mumbai
Qualification: M.Pharma in Any Specialization
Job description
Roles and Responsibilities
- Responsible for Preparation and submission of Dossier for Europe (and/or customer) and Australia market.
- Coordination with various R and D departments like AOL, F&D, bio-equivalence, packaging department and manufacturing units to get the required documents on time for the dossier.
- Co-ordination with various other departments like purchase, accounts, API vendors to accelerate registration work.
- Adequate and accurate review of documents as per current EMA, ICH and TGA guidelines and in compliance with agency's expectations.
- Preparation of quality and errorless dossiers in compliance with the agency's expectations.
- Timely submissions.
- Maintenance of status
- Responsible for preparation and submissions of query responses for submitted products.
- Co-ordination with various R and D departments like AOL, F&D, packaging department and manufacturing units to get the required documents on time for query response/variation.
- Co-ordination with various other departments like purchase, accounts, API vendors to accelerate timely submission of query response.
- Preparation of query response & Timely submission of query response with an accuracy of data.
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