Assistant Regulatory Affairs Manager

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