Assistant Regulatory Affairs Manager Sharp Hrd Services

7.0 - 12.0 years

4 - 8 Lacs

Paithan

Work from Office

Role & responsibilities Asst. Manager (Regulatory Affairs) 1. The Candidate must be M.Sc or B.Pharma or M.Pharma with 7-12 years of experience out of which minimum 3-4 years in regulatory affairs in EU, US markets, WHO GMP certified pharmaceutical formulation company. He will be responsible for all regulatory functions- domestic as well as exports. He will coordinate with other departments on regular basis. He will provide documentation support required for regulatory submission independently, including preparation and submission of dossiers for product and plant registrations in different countries as per latest guidelines. Exposure to Regulatory Audits & QMS system. Knowledge of Drug & Cosmetic Act, DPCO & All other guidelines related to pharmaceutical industries Responsible for monitoring of critical processes for R&D in compliance of operations, Quality Management and regulatory affairs. Preparation or Review of SOPs, BMRs, MFRs, PVP, PVR, PDR, Chemical compatibility of drug product/Drug substance specifications, MOA and change control to ensure compliance. To ensure new products registration and license renewal compliance to local regulations, as well as GMP, GDP and ISO requirement. Review of formulation development protocols, and technology transfer dossier (TTD) Performing literature reviews and staying up-to-date with the latest advancements in pharmaceutical research to contribute to the development of new products. Ensure compliance with regulatory requirements, including FDA and global regulations, and maintain up-to-date knowledge of industry regulations and guidelines. Oversee R&D tasks, ensuring proper documentation of records and prepared of reports submitted to regulatory authorities. R&D document and their findings to support quality assurance, and regulatory affairs processes. Co- ordination with Quality assurance, Quality control, Production, Warehouse & Engineering department, ensure GMP and EHS related to R&D functions. Establish operational, analytical and documentation standards aligned with industry best practices. Preferred candidate profile

Posted 5 days ago

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