MSN Laboratories is conducting Walk in drive on 6th Mar 2021 For Regulatory Affairs.One of the fastest growing pharmaceutical companies in the country, MSN Laboratories has nine API facilities, including oncology.. Interested and eligible candidates can attend interview on scheduled time and venue.
Walk in Details :
- Company Name: MSN Laboratories
- Location :Hyderabad
- Post Name: Regulatory Affairs
- Qualification: B Pharma / M Pharma / MSc/B.sc
- Experience: 01 to 6 years
- No of Vacancies:70
- Details of Salary: Details not provided by recruiter
- Time AndVenue : 6th March from 9.00 AM onwards MSN Laboratories Pvt.Ltd., R&D Center,plot no.12, Phase-IV,Sy.no.119, IDA Pashamylaram,ptancherru,sangareddy,502307.
- Contact: 91-8452304702/4789//+91-8452304799/040-30438786
- Selection Process: Based on interview
Job Description/Skills Required.
Department : Regulatory Affairs
Job Title: Executive / Senior Executive Experience: 1 to 8 years in API RA field Education: B Pharma / M Pharma / MSc
Department: Regulatory Affairs
1. Collecting and 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.
2. Hands on experience on the preparation of DMFs and their registration processes in the major regulatory regions [US, Canada, Europe etc]..
3. Hands on experience on preparation of drug master files, Applicants Parts, Tech Pack, life cycle management [updates and amendments] and drafting of response to deficiencies and customer DMF review comments for all global regions.
4. Should have hands on experience on eCTD regulatory submission tools.
5. Should have knowledge on the requirements to respond to the deficiencies.
6. Participation in the cross functional team meetings and providing regulatory inputs to the Product Development Teams.
Job Title: Junior Manager / Assistant Manager Experience: 1 to 8 years in API RA field Education: B Pharma / M Pharma / MSc
Department: Regulatory Affairs
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.