Job Title: Junior Manager / Assistant Manager Experience: 6 to 10 years in API RA field Education: M Sc
Department: Regulatory Affairs
Job Profile:
1. Good scientific conceptual background to the level to evaluate the processes and procedures in the area of Quality, R&D, AR&D and Production.
2. Manageable communication in English [should be able to manage regulatory and scientific discussions in the internal and external meetings and one to one interactions within the organization and with customers]
3. Manageable knowledge on the regulatory and quality guidelines from various regulatory agencies ICH, FDA, EMA, Health Canada, ANVISA, PMDA, MFDS, CFDA etc.
4. Thorough knowledge and hands on experience on the DMF registration and marketing authorization application systems in the major regulatory regions [US, Canada, Europe etc]..
5. Hands on experience on preparation of drug master files, life cycle management and drafting of response to deficiencies and customer DMF review comments for all global regions.
6. Should have knowledge on product developmental and the quality systems to ensure the regulatory compliance.
7. Should have hands on experience on eCTD regulatory submission tools.
8. Conducting meetings for the deficiencies received from various regulatory agencies and should have knowledge on the requirements to respond to the deficiencies. Ensuring that the accurate and adequate responses are sent to the authorities within the timelines defined by agencies.
9. Thorough review and ensuring that the regulatory submissions are adequate and error free with minimum open issues and closing of open issues before filing or before the receipt of deficiencies.
10. Participation in the cross functional team meetings and providing regulatory inputs to the Product Development Teams.
11. Reviewing the documents received from various departments R&D, AR&D, QA, QC and Production etc at each and every stage of manufacturing of drug substances to minimize the errors at the time of submission to regulatory agencies.
12. Review and assessment of change controls and providing guidance to the team on proposed changes.
13. Ensuring that the regulatory databases are properly maintained and updated on time to time for each regulatory activity.
Interview Date : 16-07-2022
Department : Drug Regulatory Affairs API RA Dept.
Experience : 2 to 15 Years
Position: Executive / Senior Executive / Junior Manager / Assistant Manger / Deputy Manager / Manager
Work Location : MSN R&D Center, Pashamylaram.
Venue: MSN Laboratories Pvt. Ltd,
R&D Center, Pashamylaram (V), Patancheru (M), Sangareddy (D.t), Telangana
91-8452304799/4899 & 040-30438786
 at Hyderabad on 16th July 2022){kind=link}
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