Regulatory Affairs Consultant Recruitment at Parexel, Apply Now!
Are you looking for a challenging and exciting opportunity in regulatory affairs? Parexel is currently hiring for the position of Regulatory Affairs Consultant in Bengaluru, India. If you have a strong background in regulatory and nonclinical authoring, this could be the perfect role for you. Don’t miss out, apply now!
About this Role
As a Regulatory Affairs Consultant at Parexel, you will be responsible for authoring the nonclinical sections of various applications, including Pre-Investigational New Drug (IND), IND/IMPD, New Drug Application (NDA)/Biologics License Application (BLA), biosimilars, and more. Experience with cell and gene therapy products and medical devices is desirable. You will also be involved in the review of nonclinical source documents to perform gap analysis, providing strategy and consultancy.
Key Responsibilities:
- Authoring nonclinical sections supporting various applications
- Preparing investigator’s brochure and briefing documents
- Reviewing nonclinical source documents for gap analysis
- Providing strategy and consultancy
Requirements:
- 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
- Knowledge of pharmacology, pharmacokinetic and toxicology studies
- Familiarity with ICH, OECD, FDA, EMA guidelines for nonclinical testing
- Therapeutic area knowledge in Oncology, Immunology, Cardiovascular, targeted therapies – an added advantage
Keywords: Regulatory Affairs Consultant, Parexel, Bengaluru, India, Nonclinical Authoring, IND, IMPD, NDA, BLA, Biosimilars, Cell and Gene Therapy Products, Medical Devices, Strategy and Consultancy, MPharm, MVSc, PhD, DABT, ERT, Pharmacology, Pharmacokinetic, Toxicology Studies, ICH, OECD, FDA, EMA Guidelines, Oncology, Immunology, Cardiovascular, Targeted Therapies
