Karnataka

Create and review regulatory documentation for Drug, Device and Combination product renewals and other life cycle maintenance-related submissions. Track status and progress of regulatory documentation.

BSC/MSC Chemistry, B.Pharma/ M.Pharma; QMS - Change Management, Investigation, Process and Cleaning Validation, Analytical QA, Plant IPQA, CSV, APQR. HPLC/GC, Wet Analysis and LIMS

Personnel handling this profile will be responsible for performing reactions as per the requirement of the project. They are also responsible for documenting the observations in relevant note books. They are to follow instructions from the supervisor and work in a group (or individually) to accomplish the tasks in a timely and efficient manner. 

Conduct in-depth research and analysis of rare disease markets, including competitive landscape, market dynamics, and emerging trends. Develop and maintain a comprehensive understanding of the rare disease market, including key players, product portfolios, and future opportunities. Collaborate with cross-functional teams to gather and synthesise relevant data and insights to support strategic decision-making.

Conduct literature survey and compile the scientific findings for allocated projects. Plan and perform the Pre-formulation studies, and innovator product characterization.

The conference is aimed to highlight the latest developments in the field of drug discovery & development and health care. The program will feature discussions on various aspects of pharmacy like drug discovery, pharmaceutical industrial revolution, artificial intelligence, digital transformation with technological changes, pharma engineering and clinical research. The meeting will bring together the senior executives of pharma industry and academicians paving the path for a high-level strategic deliberations that will help in shaping the future of the drug discovery, and research.

Masters degree in Natural Sciences or Bachelors Sciences in Engineering or Technology or Medicine from recognised University And, OR Scholars who are selected through National eligibility tests CSIR-UGC NET including lectureship or GATE or selection process through National level examinations conducted by central government department and their agencies and institutions.

The Regulatory Affairs Manager II is fully proficient in applying established standards and performs regulatory affairs management for moderately to highly complex international market submissions in all regions with minimal coaching. They are expected to facilitate strategic input, provide proactive contribution to submission planning, identify areas for continuous improvement, and lead cross-functional activities. They participate in the continuous improvement of processes and tools, systems.