Sr Executive - RA

Sr Executive - RA

2COMS Consulting Private Limited
Hyderabad / Secunderabad
4 - 9 Years
275000 - 775000 INR

Job Description


Job Description:
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 in CTD, 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 customer & Regulatory deficiencies.
6.Should have knowledge on product developmental and the quality systems to ensure the regulatory compliance
7.Manageable knowledge on the regulatory and quality guidelines from various regulatory agencies ICH, FDA, EMA, Health Canada, ANVISA, PMDA, MFDS, CFDA etc.
8.Ensuring that the regulatory databases are properly maintained and updated on time to time for each regulatory activity, change controls, technical queries.
9.Manageable communication in English.
10. Preparation/review of Genotoxic impurities report based on Muller alerts, toxicity data available during development stage itself.
Requirements
Sr. Executive RA based at R&D centre, Hyderabad.

Job Details

2COMS Group was established in 1993 and has been serving as a Complete Human Supply Chain Management Group for over 27 Years now. Currently there are 25+ Operation centers of

2COMS Group pan India with 550+ Employees and 3500 + Associate. As an equal opportunity organization about 60% of the employee workforce consists of women employees. 2COMS Group also has 6 National Awards and 60+ Corporate awards/Recognitions under the kitty.

2COMS Group broadly functions on the following verticals :
  • Recruitment and Apprenticeship
  • Staffing
  • Skill Development
  • Social Entrepreneurship and CSR

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