Regulatory Operations
Job Description:
Job Responsibilities:
• The individual is responsible for processing of regulatory documents, use of document management tools, perform quality checks on own and other team members' to ensure compliance with Regulatory Authority formatting standards.
• The individual needs to work effectively with Operations team members, Regulatory colleagues and Publisher to assure high quality documents and to meet established deadlines of submission packages.
• The Individual must have excellent written & oral communication skills in English & be able to work with business partners globally.
• The individual will also perform other operations activities as needed. Such as managing of MRP and PSP inventories and its documents in DMS, QM document coordination/management, RIMS – document upload, and so on.
• The individual supports departmental projects and less experienced colleagues.
• The individual contributes in settings standards and developing training materials on document operations activities.
• The individual contributes in process improvement, system enhancement, and provide assistance in troubleshooting issues with software and processes.
• Life Sciences Graduation
• 2-4 years Regulatory/R&D experience or related area.
• Basic understanding with pharmaceutical regulatory documents.
• Verbal and written communication skills.
• Ability to quickly learn, and use computer based systems.
• Must be process oriented with a strong attention to detail.
• Ability to work in a fast paced team environment and re-prioritize work to meet business needs.
Additional Details :
Experience: 2
Gender : female
Interview process : Face to face
Working days - 5 Days (Mon - Fri)
Work timings - 8:30 am To 5:00pm
Location - Andheri
Age bracket: 21 to 27
Contract period, auto-renewable or not: 1 year. Can be renewed with evaluation.
On Third Party Payroll (Talisman HR)
Interested can share updated cv on search@talismanstaffing.com or What's app : 9136435341
Key Skills :
Company Profile
Our client is an American MNC Pharmaceutical Company.
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- Interested candidates are requested to apply for this job.
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