Bangalore

Contribute to preparation including authoring where relevant and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.  Good understanding of regulatory guidelines, regulatory framework, including regional trends, for various types of applications and procedures.

Candidate with project management experience in Discovery Sciences along with Commerical or Product launch, Product strategy experience would be preferred; should be adept at managing project milestones, budget and stakeholders.

The candidate will be responsible for preparation and submission of dossiers for NCEs and NBEs and will present it to relevant internal and external stakeholders. The candidate will represent the company with Indian regulatory agencies, including CDSCO, RCGM, Central Bureau of Narcotics and Karnataka drugs control department.

Masters or Ph.D. in Biotechnology, Genomic Science, Biochemistry, Bioinformatics, Biomedical, Bioprocessing with a strong technical knowledge in the respective core domain and passion for life science-related industry segments.

Graduate or post graduate degree in BPharm/MPharm, PHD, BDS Dental, BSC/MSC or equivalent job experience with comprehensive Medical Writing knowledge of theories, principles and concepts

The candidate must possess a thorough understanding of relevant disease biology, the clinical landscape, emerging technologies, and the competitive environment. The candidate should demonstrate exceptional laboratory technical skills in cell and molecular biology, and, or in vivo pharmacology and proficient at devising strategic solutions to identify and resolve potential challenges.

Conduct preliminary review of laboratory results relative to established protocol-specific reference range guidelines, using relevant clinical laboratory experience and compares current results with prior laboratory values to evaluate or note clinically significant increases, decreases and contacts the investigator site for pertinent additional clinical contact for distribution to project team

Promote pharma product portfolio to healthcare professionals and institutions. Develop and maintain strong relationships with doctors, pharmacists, and key opinion leaders. Achieve sales targets and ensure market growth in the assigned territory.

UNDERSTAND DESIGN, SETUP, AND EXECUTION OF IN VIVO PHARMACOLOGY MODELS FOR EXPERIMENTS ASSOCIATED WITH GROSS IMMUNOLOGY, SOLID TUMORS, AND HEME-ONCOLOGY