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 : Regulatory Affairs Consultant
Job Description
• 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)
• 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 responses to heath authority queries
Candidate Profile
• Master's in pharmacy/PhD/BDS/MBBS
• More than 8 years of experience in regulatory domain with knowledge in Biologics/Biosimilars
• Therapeutic area knowledge: Oncology, Immunology, Cardiovascular, targeted therapies etc.
Additional Information
Qualification : Master's in pharmacy/PhD/BDS/MBBS
Location : Bengaluru, Karnataka, India
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 10th April, 2023
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