Thorough knowledge of EU, MENA and ASEAN markets country requirements, regulatory affairs procedures for initial submission, licensing, post-approval submission management
Doctoral Degree in Science from a recognised university or equivalent in stem cell biology, developmental biology, pharmacology, and or maternal or child health.
Must have at least 02 years experience in hospital/clinics. In case B.Pharm candidate is not available then D.Pharm candidates with minimum 02 years experience will be considered. Must have computer knowledge.
Responsible for Execution of Placebo, Scale up & Trial batches. Review Validation protocol, Report, responsible for validation batches manufacturing. Preparation of scale up and trial batch summary to support the commercialization of products.
M.Pharma, Masters in any biological sciences and life sciences with prior experience in handling laboratory mice or rats with experience in molecular biology techniques is desirable. Experience in molecular biology techniques such as PCR, DNA/RNA extraction, gel electrophoresis, genotyping
The Project Manager will play a central role involving coordinating the project’s multidisciplinary team of doctors, nurses, psychologists, social workers and office staff at the Srinivaspura project site office and in the field.
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 Associate (Labelling)