Parexel Hiring!! Regulatory consultant for Clinical Regulatory Writing

We are looking for an experienced candidate who can undertake:

Authoring of the clinical sections supporting various

Applications:

Pre-Investigational New Drug (IND), IND/IMPD (Investigational Medicinal Product Dossier), New Drug Application (NDA)/Biologics License Application (BLA) for New Biologic entities, Biosimilars & New chemical entities.

Clinical sections of investigator brochure, briefing documents, CTD modules 2.5, 2.7 (Includes safety and efficacy summaries) etc.

Qualification: Masters in Pharmacy/BDS/PhD/MBBS, advanced degree preferred.

More than 8 years of Industry experience in regulatory domain with knowledge in Biologics/Biosimilars; well versed with US FDA, EU, MHRA, etc. regulations, guidelines and procedures

Therapeutic area knowledge in Oncology, Immunology, Cardiovascular, targeted therapies - an added advantage

Apply Now: Click Here