We are looking for candidate with experience in Regulatory Affairs department for Apitoria Research Centre (100% subsidiary of Aurobindo Pharma)

We are looking for candidate with experience in Regulatory Affairs department for Apitoria Research Centre (100% subsidiary of Aurobindo Pharma) located at Hyderabad.

Qualification: MSc Chemistry / M.Pharm

Experience: 4 – 8 Years experience in API Regulatory Affairs

Department: Regulatory Affairs (API)

Skill Set:

Well versed in regulatory guidelines and filing requirements/procedure.

Expertise in eCTD handling.

Good Communication & Interpersonal Skills with expertise in MS Office.

Job Description:
1. Accountable for new DMF submissions globally as per the market requirement.
2. Ensure to submit responses / Life Cycle Management.
3. Evaluation of Change Controls.
4. Supporting to plant during regulatory audit for compliance on regulatory perspective.
5. Accountable for New /revision of pharmacopeial monographs changes updating in DMFs / CEPs/ communication to CFTs and customers.
6. Smooth co-ordinate with cross functional team (CFTs) to get the required data for regulatory submissions in timely manner.
7. Ensure to submit all pre/ post change notifications with appropriate documents / Sections to customers well in time.
8. Coordinating with marketing department / internal formulation for smooth regulatory filings in timely manner.

Interested candidates with relevant experience can send your profiles to madhu.gudipally@apitoria.com

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