Metrochem API Walk In Interview For Junior Manager / Asst Manager- API Regulatory Affairs
.png "Metrochem API Walk In Interview For Junior Manager / Asst Manager- API Regulatory Affairs") |
Metrochem API Walk In Interview For Junior Manager / Asst Manager- API Regulatory Affairs |
Position - Junior Manager / Asst. Manager- API Regulatory Affairs (API RA) - Unit - Research & Development, Shapurnagar, Hyderabad
Qualification Required - M.Sc Org Chemistry Only
Experience - 7- 11 years in API RA
Job Description For Metrochem API -
1 Examining the conformity of all documents for approval must be compliant to all relevant regulations, rules and standards and taking part in the conformity assessment procedure with coordination of all concerned departments.
2. Developed and maintained an in dept , ongoing knowledge of Guidelines, Regulations, Directives and requirements for submission.
3.Communicate regulatory information to multiple departments and ensure that information is interpreted correctly and support the relevant departments in fulfilling the regulatory requirements
4. Handling of Authority and Customer Queries.
5. DMF or Dossier Preparations and submission.
6. Providing the regulatory strategic note for building the product by exploring various literature and summary basis of approval provided by various regulatory authorities.
7. To provide the regulatory in-puts for the change controls assigned.
8. Make sure the proper regulatory data base maintenance.
9. Building the regulatory awareness.
10. Genotoxic impurities assessment and control strategy.
11. Nitrosamine risk assessment evaluation.
12. New DMF and amendment review in technical aspect and regulatory compliance.
13. Serves as a liaison between the regulatory bodies and operating devisions of the company.
14. Tracking and monitoring the process of submissions.
15. Enriching the quality of documents in-line with the current regulations.
16. Regulatory Compliance Facilitate quick closure of internal and external outstanding regulatory issues.
17. Regulatory intelligence Responsible for assessment of regulatory consultants and trade consortium
18. Team empowerment Responsible for mentoring reportees
19. Team empowerment Responsible for identifying appropriate training for the team.
20. Technical and managerial skills to understand and guide cross functional teams on process development, analytical development , process scale up , product characterizations.
21. Experience and expertise to develop regulatory strategy from development stage to filing and approval.
Walk In Location - R&D Centre -Ranga Bhujanga Theatre Road, Shapurnagar, Hyderabad
Walk In date - 26th June 2023 to 30th June 2023
Time- 10.00 am to 5 pm
Contact - 8886659021 / 8187892413
Cannot attend for Interview can send CV's to - gowtham.adapa@metroapi.com
To be carried - Updated CV, Aadhar, 3 months Payslips & 6 months Bank Statement
For any clarifications contact 8187888831
2. Developed and maintained an in dept , ongoing knowledge of Guidelines, Regulations, Directives and requirements for submission.
3.Communicate regulatory information to multiple departments and ensure that information is interpreted correctly and support the relevant departments in fulfilling the regulatory requirements
4. Handling of Authority and Customer Queries.
5. DMF or Dossier Preparations and submission.
6. Providing the regulatory strategic note for building the product by exploring various literature and summary basis of approval provided by various regulatory authorities.
7. To provide the regulatory in-puts for the change controls assigned.
8. Make sure the proper regulatory data base maintenance.
9. Building the regulatory awareness.
10. Genotoxic impurities assessment and control strategy.
11. Nitrosamine risk assessment evaluation.
12. New DMF and amendment review in technical aspect and regulatory compliance.
13. Serves as a liaison between the regulatory bodies and operating devisions of the company.
14. Tracking and monitoring the process of submissions.
15. Enriching the quality of documents in-line with the current regulations.
16. Regulatory Compliance Facilitate quick closure of internal and external outstanding regulatory issues.
17. Regulatory intelligence Responsible for assessment of regulatory consultants and trade consortium
18. Team empowerment Responsible for mentoring reportees
19. Team empowerment Responsible for identifying appropriate training for the team.
20. Technical and managerial skills to understand and guide cross functional teams on process development, analytical development , process scale up , product characterizations.
21. Experience and expertise to develop regulatory strategy from development stage to filing and approval.
Walk In Interview Details Of Metrochem API
Walk In Location - R&D Centre -Ranga Bhujanga Theatre Road, Shapurnagar, Hyderabad
Walk In date - 26th June 2023 to 30th June 2023
Time- 10.00 am to 5 pm
Contact - 8886659021 / 8187892413
Cannot attend for Interview can send CV's to - gowtham.adapa@metroapi.com
To be carried - Updated CV, Aadhar, 3 months Payslips & 6 months Bank Statement
For any clarifications contact 8187888831
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