Stallion Laboratories incorporated in 1988 as an integrated private sector Pharmaceutical Formulation Manufacturer, has acquired an unmatched record of managing niche product in formulations with a WHO GMP approved production facility and GLP qualified stringent quality control. The path of success lies in its belief of creativity and no negotiation with the quality of work.
Post : Sr. Manager / AGM
Department : Regulatory Affairs
Location : Corporate Office
Markets : US, EU, UK, Canada, China, Australia.
Salary is no bar for potential leaders.
Job Description
• Well Versed experience in managing entire regulatory product lifecycle in listed regulated markets.
• Providing White Paper Strategy to CFTs throughout life cycle starting from development, execution, filing to till approval followed by commercial launch.
• ANDA, ANDS, IDL and Dossier filing with utmost Quality and by complying all current regulatory requirements which includes but not limited to original filing, deficiency handling, post approval variation /supplements filing.
• Keeping individual updated for ail current regulatory trend and providing regulatory science awareness at organization level.
• Expertise in providing Regulatory strategic solutions based on experience with different regulated Agencies to come out of box thinking.
• Well versed experience of managing different clients, third party partners on CMO projects.
• Excellent Project management, co-ordination, communication and interpersonal skills
• Having a sound understanding on Regulatory impact assessment on business continuity and contingency perspective.
• Providing tactical and strategic decision on managing critical changes during commercial evel to ensure regulatory compliance is maintained.
• Exposure of participating Regulated Audit is preferred
• Guiding APD, P&D, Sourcing, QA QC, Mfg and Other teams on current regulatory requirements and providing technical knowledge on immediate implementation aspects.
• Conducting periodic regulatory and technical training throughout organization
Job Location : 8th Floor, Devpath, B/H Super Mall, Near Lai Bunglow, Navrangpura, Ahmedabad, Gujarat 380009
Salary is no bar for potential leaders
Please send your Cv on : avnish.patel@stallionlabs.com and do specify subject line with Dept. Name.
Last Date : 20th January, 2024
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