Job Description
Job Description
About you role
We have vacancy for Global Regulatory Expert role in Regulatory Affairs team. We are looking for Assistant Manager . This individual will be based in Mumbai/ Hyderabad. The candidate has the possibility to utilize his/her own strengths with the support of the professionals.
Your Key Responsibilities
About you role
We have vacancy for Global Regulatory Expert role in Regulatory Affairs team. We are looking for Assistant Manager . This individual will be based in Mumbai/ Hyderabad. The candidate has the possibility to utilize his/her own strengths with the support of the professionals.
Your Key Responsibilities
- Responsible for preparation / checking / review of pharmaceutical / quality part (all forms) of registration dossiers and variations /amendments / annual reports / renewals as applicable documents according to EU regulatory requirements.
- To identify and classify the changes as per EU regulatory variation guidance.
- To prepare response to regulatory deficiencies letters according to EU regulatory requirements
- To collaborate with other departments/partners
- To maintain lists/documents/records
- Responsible for keeping Orion internal ...
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