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
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
Experience in authoring of the nonclinical 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 chemical entities, new biologic entities, biosimilars. Experience with cell and gene therapy products and medical devices is desirable.
Nonclinical sections of investigator’s brochure, briefing documents/ meeting information package for health authority meetings, nonclinical overview (module 2.4) and nonclinical summaries (module 2.6) as per CTD guidelines etc.
Strategy and Consultancy : Experience with review of nonclinical source documents to perform gap analysis is an added advantage.
Candidate Profile
• MPharm/ MVSc/ PhD/ Relevant post graduate degree, advanced degree preferred.
• DABT/ERT certification is desirable but not mandatory.
• More than 8 years of Industry experience in regulatory domain with knowledge on pharmacology, pharmacokinetic and toxicology studies conducted for filing an IND, NDA and BLA application. Well versed with the ICH, OECD, FDA, EMA guidelines for nonclinical testing of pharmaceuticals.
• Therapeutic area knowledge in Oncology, Immunology, Cardiovascular, targeted therapies - an added advantage
Additional Information
Qualification : MPharm/ MVSc/ PhD/ Relevant post graduate degree
Location : Bengaluru
Industry Type : Pharma / Healthcare / Clinical research
End Date : 20th November, 2023
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