Monitor the API, formulated products against stipulated conditions mentioned in the batch production record. Conduct certification of batch production records for compliance and stage wise completion.
Bachelors degree in a scientific, health, communications, technology health related field. Demonstrated experience in technical/ regulatory scientific writing.
Preparation of original DMF, amendments, Annual reports and Review of adequacy of documents for submission. Compilation, review and submission of various Drug master files for US, EU, TGA, Canada and other markets as per respective regulatory guidelines and checklist
B.Pharm, M.Pharm, B.E, B. Tech with 6 to 10 years of experience in Supervising and Controlling Production areas like Aseptic Filling, Vial Washing, Autoclave, Lyophilizer, Visual Inspection and Packing. Should have knowledge of QMS activities
Unichem Laboratories Ltd., is looking for dynamic individuals with ambitious career aspiration having Regulatory Exposure for the opportunities at our pharmaceutical facility in Ghaziabad
Prepares, literature review, abstracts, posters, and slide sets, and Manuscripts sophisticated working from various data sources including clinical study reports, patient profiles, protocols etc.
Maintaining detailed records of studies as per FDA and other required guidelines, including things such as drug administration and subject specific case report forms.
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.