Regulatory Affairs Manager

2COMS Consulting Pvt. Ltd.
  • Gurgaon
  • 10-11 lakh
  • 2-7 years
  • Views
  • 18 Jan 2017

  • Legal

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Review of quality and manufacturing end data for various in-house developed APIs for regulatory adequacy for compilation of Drug Master Files/Registration Dossiers, Amendments/Variations, Technical Data Package/Open Parts of DMFs for In-House developed APIs and their updation to meet current regulatory requirements
-Review of outsourced APIs to support GMS and Regulatory Affairs-Pharma in connection with Drug products filings for Regulatory adequacy
-To coordinate with Chemical Research Division, Analytical Department and Manufacturing locations in generating data as per the requirements of regulatory agencies
-To ensure reposition of API dossiers into central repository and to provide information about regulatory commitments in timely manner
Assessment and Planning of Work
The work is assigned by job supervisor (Superior) based on filing priorities and business requirements

Key features:
-Interaction with Chemical Research Division, Analytical Department and Manufacturing locations to generate data as per current regulatory requirements in a timely manner
-To provide technical information to API customers for development of API Business
-To provide support to Regulatory Affairs-Pharma in their regulatory submissions to secure timely approvals
-To provide technical inputs to GMS for outsourced APIs/Key Intermediates for regulatory adequacy

The position is required to interact with the following:-
-Analytical Research
-Chemical Research Division
-Regulatory Affairs-Pharma
-Quality Assurance
The Position is required to provide support to the following:-
-Global Material Sourcing
-API Business
Competencies Required:
Technical Competencies:
The Technical competencies required are:
-Knowledge of dossier compilation skills as per country specific requirements
-Good oral and written communication skills
-Should have knowledge of current regulatory requirements of different countries
-Adequate knowledge of Microsoft office (MS-Word, MS-Power Point and MS-Excel) and Internet surfing
Behavioral Competencies:
-Time management and work planning
-Customer responsiveness
-Good Interpersonal Skills
-Team Work
-Strong Communication Skills
-Willingness to learn

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About Organisation

2COMS Consulting Pvt. Ltd.