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Regulatory Affairs Associate (GPR & Reg Ops)

  1. Biologics
  2. Documentation

This vacancy has now expired. Please see similar roles below...


Job Description

- CTD Dossier Drafting (Modules 2, 3, 4)

- Regulatory writing

- Clinical Regulatory & Pharmacovigilance Regulatory

- Preparation of Tox applications, CTAs, MAAs

- Regulatory commitment & compliance

- Any other Regulatory activities on need basis

- Support Line manager & Matrix manager in Regulatory projects

- Coordination and interaction with cross-functional teams

Mandatory Skills

Effective Regulatory/dossier writing skills; Effective interpersonal & communication skills; Good Analytical, reasoning, scientific & Regulatory aptitude; Positive attitude & behaviour


Qualifications

M.Sc / M.pharm


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