Novartis Chemistry & Pharmacy Submission Coordinator Vacancy
Novartis announces job opening for Coordinator. Chemistry and Pharmacy job opening 2022. Chemistry Coordinator job opening 2022. Candidates with science degree in chemistry and pharmacy may apply for the post of submission coordinator. Intrested and eligible candidates may check out all the details on the same below:
Job Title: RA CMC Senior Submission Coordinator
Location: Hyderabad, AP
Job Id: 355682BR
Elibgility Criteria & Experience:
Science Degree (Chemistry, Pharmacy) or equivalent
Minimum 5 years in regulatory and/or experience in the pharmaceutical industry.
• Working experience of chemistry/biotechnology, analytics, or pharmaceutical technology. Knowledge is of the drug development process is desirable.
• Ability to work successfully with global project teams and prioritize activities considering timelines and workload.
• Effective planning, organizational and interpersonal skills
• Prior publishing experience desired and Computer literacy.
Your responsibilities include but not are limited to:
• Independently perform compliance and operational support including QC and DA checks, CMC contact for some countries, compliance/regulatory database entry and reports and ensure appropriate eCTD operator attributes, module chapters
• Create submission documentation such as folders, metadata forms, RA request forms, populating RA tracking sheets, letters, and various Health Authority forms
• Proactively ensuredocumentation is eCTD compliant, DA checked, finalized and eCTD filenames assigned. Coordinate data/KPIs required for reports within RA-CMC.
• Independently coordinate, prepare, compile and track CMC submissions for delivery to RA Operations.
• Support RA CMC Manager to handle Country Organization (CO) request in the
RA CMC ticketing system
• Perform super-user role of documentation system/ support super-user for e.g.account requests/ modifications as assigned Coordinate IND Annual reports.
• Coordinate submission documentation from third parties to ensure compliance with eCTD requirements.
• Acquire and maintain GMP Certificates and Manufacturing Authorizations required for RA CMC submission in the Document Management System. Coordinate preparation of declarations required for submission in RoW countries.
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