PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.
Post : Senior Regulatory Affairs Consultant
Job Description
Expertise/Experience
Subject Matter Expert in
Submission writing/Technical writing pertaining to Pre-Investigational New Drug authoring(IND), IND/IMPD authoring and/or New Drug Application (NDA)/Biologics License Application (BLA)
Reviewing/Preparation of the clinical regulatory documents for Innovator products (new filings/hybrid filings) listed below, not limited to:
• Briefing documents/meeting packages
• General investigation Plan
• Investigator Brochures
• CTD modules such as Module 2.5 (Clinical overview), Module 2.7(Clinical summary and tabulations including Summary of Safety (ISS), summary of Efficacy (ISE)
Preparing/reviewing responses to heath authority queries
Candidate Profile
Masters in pharmacy / PhD / BDS / MBBS, advanced degree preferred
Around 15 years of overall experience in Industry/regulatory domain with knowledge Biologics/Biosimilars
Therapeutic area knowledge : Oncology, Immunology, Cardiovascular, targeted therapies etc.
Additional Information
Location : India
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 15th December, 2022
See All Ph.D Alerts M.Pharm Alerts B.Pharm Alerts Hyderabad Alerts
See All Other Jobs in our Database
.png)
