Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards
Liaise with Global Regulatory Affairs, Medical, Clinical and Pharmacovigilance teams to obtain required documentation and ensure successful submissions.
Solid organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines
To co-ordinate with Cross Functional Team for getting various documents required for filing the product in India. Responsible for reviewing CMC documents to be submitted in dossier as per regulatory guidelines.
SunGlow was incorporated in January 2010 and was founded by a group of experienced industry professionals. Our Corporate office is located in Chennai, India.
Bachelors degree in Bioinformatics, Computational Biology, Computer Science, Life Sciences, or a related discipline. Master's degree preferred. Career in Regeneron
To prepare and review documents like Risk Assessment protocols for product change over, Cleaning/Process Validation protocols, Master Formula Records, Batch Manufacturing Records. Review technology transfer documents for Mammalian and Microbial products with coordination with R&D, QC and RA.
Design and evaluate oncology clinical trial frameworks — including study protocols, patient enrollment strategies, and regulatory compliance considerations
Assist in day-to-day production activities as per SOPs. Conduct basic chemical handling, mixing, and batch processing.
Monitor production processes and record process parameters.