General Manager - F & D (Regulatory Market)

Evoke HR Solutions Pvt. Ltd
  • Mumbai
  • Confidential
  • 15-20 years
  • 12 Aug 2015

  • R&D/ Research & Development

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Company :

A well know leading leading pharmaceutical( F & D)Company. Voted as worlds best company to work.

Qualification : PH.D & M.Pharma

Roles and responsibilities:

1.Formulation department for handling solid oral dosage forms aimed for US and other regulated markets from its initial stage in all aspects like induction & building of new team, procurement of all required equipments & instruments, detailed time line planning for the development of the projects.

2.Managing and providing guidance to a team members from the conception of a new project till its submission to the respective markets.

3.Implementation of QbD initiatives for successful Qbd filings from the site.

4.Preparation & monitoring of Capex & Revenue Budgets for the department.

5.Coordination with the respective departments based in India, US & EU counterparts etc.

6.Responsible for Technology Transfer team for transfer of products to commercial scale.

7.Responsible for query reply of different Regulatory bodies and coordinating with Regulatory Affairs department to fulfill requirement of dossier submissions.

8. Handling of investigations, troubleshooting and implementation of solutions .

9.Implementation of systems for day to day activity in Laboratory.

Competencies/Skill sets for this job

Regulatory Affairs Pharma Solid Oral Dosage F & D QbD

Job Posted By

About Organisation

Evoke HR Solutions Pvt. Ltd