Regulatory Affairs Job Vacancies in Thane

Urgent OpeningRegulatory Affairs Manager (Veterinary Pharmaceuticals)Veterinary Pharmaceutical Manufacturing CompanyPalghar, MaharashtraQualification B.Pharm / M.Pharm / M.V.Sc. / M.Sc. or an equivalent qualification. Additional certification in Regulatory Affairs will be an added advantage. Experience 8-12 years of experience in Regulatory Affairs within the veterinary or pharmaceutical industry. Experience in handling product registrations and regulatory approvals. Regulatory Affairs Manager to oversee all regulatory activities for veterinary pharmaceutical products. The candidate will be responsible for product registrations, dossier preparation, regulatory submissions, license management, and ensuring compliance with all applicable veterinary pharmaceutical regulations.Key Responsibilities Manage regulatory affairs activities for veterinary pharmaceutical products. Prepare, review, and submit product registration dossiers to regulatory authorities. Coordinate with the CDSCO, State FDA, and other regulatory authorities for approvals and licensing. Ensure compliance with the Drugs and Cosmetics Act & Rules, Schedule M, GMP, and other applicable regulations. Prepare and maintain regulatory documentation, technical files, and product dossiers. Handle applications for manufacturing licenses, product permissions, and renewals. Coordinate with QA, QC, Production, R&D, and Marketing departments for regulatory compliance. Review product labels, package inserts, and artwork to ensure regulatory compliance. Respond to regulatory queries and deficiency letters from authorities. Monitor changes in regulatory guidelines and implement necessary updates. Support internal, customer, and regulatory audits. Maintain regulatory records and ensure timely submission of required documents. Required Skills Strong knowledge of Veterinary Pharmaceutical Regulations. Experience in CDSCO, State FDA, and product registration processes. Knowledge of Drugs and Cosmetics Act & Rules, Schedule M, and GMP. Ability to coordinate effectively with cross-functional teams and regulatory authorities.

Urgent OpeningFactory Manager (Veterinary Pharma)Veterinary Pharmaceutical Manufacturing Company. Palghar East, Maharashtra Qualification B.Pharm / M.Pharm / B.Sc. / M.Sc. / B.E. / B.Tech. or an equivalent qualification. Additional qualification in Operations or Industrial Management is an added advantage. Experience 10-15 years of experience in the pharmaceutical or veterinary pharmaceutical industry. Minimum 5 years of experience as a Factory Manager or Plant Manager. The Factory Manager will oversee the overall operations of the veterinary pharmaceutical manufacturing facility in the Company. The candidate should have strong knowledge of Production, Quality Assurance (QA), Quality Control (QC), Warehouse, Engineering, Maintenance, Regulatory Compliance, and Dispatch to ensure smooth plant operations and compliance with GMP and regulatory standards. Key Responsibilities Manage the overall operations of the manufacturing plant. Ensure production targets are achieved as per the production plan. Supervise and coordinate Production, QA, QC, Warehouse, Engineering, Maintenance, and Dispatch departments. Ensure compliance with GMP, GLP, SOPs, Schedule M, and other regulatory requirements. Required Skills Strong knowledge of Production, QA, QC, Warehouse, Engineering, Maintenance, and Regulatory Affairs. Good understanding of GMP, GLP, GDP, Schedule M, and Quality Management Systems (QMS). Experience in handling regulatory inspections and audits. Excellent leadership, decision-making, and people management skills. Strong planning, problem-solving, and communication abilities. Proficiency in MS Office and ERP systems.

Urgent RequirementDocumentation Specialist, Cosmetic Regulatory Affairs A Cosmetic Company Located at Goregaon East, Mumbai, MHJob Location: Goregaon, Mumbai (Candidates Preferred Nearby Location - Mumbai Western Suburban, i.e. Dadar to Borivali only) Work Mode: Hybrid (Primarily work from Home with periodic office visits as required) Qualification: Bachelors degree in Science, B.Sc. / M.Sc. in Microbiology / Chemistry / Biotechnology with strong academic performance (Convent Preferred) Experience: Freshers / Experienced candidates with a keen interest in regulatory compliance or QC looking for a transition into regulatory roles Job Description: Efficiently and accurately create high-quality documents while collaborating directly with clients as part of a team. Responsibilities and Duties: Ensure all work is accurately completed in the stipulated timeline. Review, scrutinize & Prepare registration dossier Communication with Band manufacturer, Importer. Skills - Mandatory Excellent English oral and written communication skills Excellent eye for detail Good time management and organisational skills Ability to adapt to any process changes Knowledge of regulatory guidelines will be an Advantage. Software Skills - Basic: Microsoft Office Salary: as per Industry Standards

Should have good knowledge of preparing Dossier of Drugs & Feed Supplements in different countries Managing regulatory affairs of the organization & its subsidiaries / associates. Liaising with regulatory bodies like State and Central FDA, DCI, etc. Well conversant with Drug law/feed supplement regulation. Compilation and preparation of tender documents. Coordinating documents & process for Audit. FDA Documentation & Portal handling. FSC, legal action and other statutory document perpetration and compilation.