AGM/ DGM Regulatory Affairs

Ideal Consultants - Hyderabad
  • Hyderabad
  • 18-30 lakh
  • 15-25 years
  • 14 Jul 2015

  • Compliance/ Regulatory

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Has management responsibility that includes providing line management, support and development of staff as well as providing technical and regulatory oversight and guidance to the department and other functional areas at the site.
Position will ensure continuous and vigilant evaluation of regulatory strategy of products managed by group to identify any concerns and communicate the findings /potential solutions to the Head, RA and senior management, as required.
The position is expected to organize and lead contract with regulatory agencies or third parties

Basic Qualification required;
Master in Biological science (Immunology, Microbiology, Virology, and Bacteriology)
Experience:15 -25 years
(At a minimum, 4-5 years of prior management experience)
Areas of specialization;
Out of total, 8-10years of Regulatory Affairs experience (biological will be preferred).
Good knowledge of regulatory pathways and options for India.
Ability to manage multiple priorities efficiently.
Experience working on Project teams preferred.
.understanding of GMP, GDP&GLPs.
Preparation/Review/APProval of CTD dossier.
Skills expected; communication (written and verbal), Organizational (meeting timelines),
Anticipation of regulatory consequences, Risk-benefit analysis, Think analytically and critically.

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Ideal Consultants - Hyderabad