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Regulatory Affairs Executive

Regulatory Affairs Executive

1 - 5 years

0 Lacs

Mumbai Maharashtra India

Posted:1 month ago| Platform:

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Skills Required

authorization analysis management development addition excel database

Work Mode

On-site

Job Type

Full Time

Job Description

Job Description About the Role: Responsible for preparation and compilation / review of registration dossiers as per current regulatory requirements of Russia CIS / ROW region to obtain the necessary authorization. Responsibilities: Maintain awareness and knowledge of current regulatory guidelines/legislation and ensures best regulatory practice all time. Provides regulatory guidance to internal stakeholders, to allow them to make key decisions on business-critical activities and project feasibility. Review, analyse and prepare/compile documents generated by R&D, Operations, QA and other related departments as per current regulatory requirements. Handling queries from Regulatory Bodies from time to time. Regulatory gap analysis and variation application filing accordingly. Handling Lifecycle management projects. Coordinating project meetings and decision-making processes. Review of New product development documents. Maintaining regulatory trackers. Providing Master dockets to site. Review of Change control documents. Additional responsibilities may be given in addition to the above as per business requirement and JD can be altered at the discretion of the superiors. Qualifications M.Pharma Required Skills: Should have minimum 1-5 years of experience. Preferred Skills Excel, Database, etc Show more Show less

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Regulatory Affairs Executive