• Good knowledge of Regulatory Requirements like ANVISA/MCC/EU/UK MHRA and ICH Guidelines• Well versed with eCTD/ACTD submissions• Good experience and knowledge about review of documents like Batch Manufacturing & Packing Records, Process Validation Protocols, COAs, Stability data etc. in a pharmaceutical company.
Summary
Compensation: Best In Industry
Education: UG - Any Graduate - Any Specialization,Graduation Not Required PG - Any PG Course - Any Specialization,Post Graduation Not Required
Industry Type: Pharma/ Biotech/Clinical Research
Role: Regulatory Affairs Mgr
Functional Area: Healthcare, Medical, R&D
Desired Candidate Profile
• Good knowledge of Regulatory Requirements like ANVISA/MCC/EU/UK MHRA and ICH Guidelines
• Well versed with eCTD/ACTD submissions
• Good experience and knowledge about review of documents like Batch Manufacturing & Packing Records, Process Validation Protocols, COAs, Stability data etc. in a pharmaceutical company.
Job Description
• Knowledge of/Experience in Finished Formulation Product Registration Dossiers/Documents filling for Solid Dosage forms
• Creation and Compilation of International regulatory dossiers for Regulatory Agencies across countries like TGA/MCC/UK MHRA/ANVISA
• Preparation of Product Dossiers in multiple dosage forms like tablets, suppositories, oral suspensions etc
• Coordinating with concerned departments like Quality Assurance/Quality Control/Production to procure the documents for compilation of dossiers and meet the submission timelines.
• Extend complete technical support to the business team, by submitting the Registration Dossiers within the timelines to obtain international market clearances.
• Facilitate quick response to technical queries from various regulatory agencies
• Coordinate with International marketing authorization persons to manage and ensure compliance of regulations and on-time submissions
• Review of all technical documents for adequacy and accuracy before compilation/submission of dossiers
• Study the Regulatory Requirement and Prepare Strategy to enter new markets with the help of the business development team.
• Guide and Assist the R&D team with relevant information on various studies required for specific countries like ANVISA/TGA/MCC
• Conduct Quality Review of various documents like BA/BE Studies/Stability Studies
Keywords: Regulatory affair, Product registration, Registration Dossiers,Regulatory Agencies, Product dossiers,Technical Documentation,
Company Profile
A major Pharma Co.
Contact Details
Company Name: Client of India Pharma People
Executive Name: Mr Deepak Sanhotra