Apitoria Pharma Private Ltd (100% subsidiary of Aurobindo Pharma) hiring for Regulatory Affairs (API)

We are looking for candidate with experience in RAD US & Europe markets for Apitoria Pharma Private Ltd., (100% subsidiary of Aurobindo Pharma) located at Hyderabad.

Qualification: MSc Chemistry
Experience: 8 – 10 Years experience in API Regulatory Affairs
Department: Regulatory Affairs (API)
Designation: Deputy Manager / Manager
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. To guide the team on Regulatory requirements for new process /Cost improvement processes (CIP).
4. Evaluation of Change Controls.
5. Supporting to plant during regulatory audit for compliance on regulatory perspective.
6. Accountable for New /revision of pharmacopeial monographs changes updating in DMFs / CEPs/ communication to CFTs and customers.
7. Smooth co-ordinate with cross functional team (CFTs) to get the required data for regulatory submissions in timely manner.
8. Ensure to submit all pre/ post change notifications with appropriate documents / Sections to customers well in time.
9. 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