Assistant/Deputy Manager – Regulatory Affairs – API

  Regulatory Affairs

Job title: Assistant/Deputy Manager – Regulatory Affairs – API


Job description: Our client one of the fastest growing manufacturers of Active Pharmaceutical Ingredients (APIs), Veterinary, Intermediates and specialty chemicals looking for :

Deputy Manager – Regulatory Affairs

Location: Mumbai (Borivli)

Major Accountabilities

1.To ensure API regulatory activities within Organization as per stipulated time schedule.

2.To communicate with the customers and health authorities for API regulatory related activities.

3.To provide the regulatory support/ advice/ guidance to the concerned API sites/ FDF sites/ Development centres.

4.To assure the quality of DMF, its submission and its maintenance taking into consideration company business.

5.To co- ordinate and collaborate with QA/ QC/ Production/ Development department of API sites and Formulation regulatory department.

6.To implement corporate HSE Guidelines in area of Operation Responsibility

7.Any other responsibility assigned by management with API regulatory department.

Key Performance Indicators

1.Timely readiness of API regulatory documents / DMFs for new submissions / variations / updates.

2.To maintain high degree of quality of documents required for submission

3.Adequate deficiency responses within stipulated timelines.

4.Maintenance of submitted DMFs and updating on DMFs.

5.Compliance to KPIs of global regulatory department

Expected salary:

Location: Mumbai, Maharashtra

Job date: Sat, 27 Aug 2022 22:09:38 GMT

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