Job Description

Company Overview Selective Global Search Pvt Ltd is a renowned recruitment firm in India. We specialize in providing exceptional staffing solutions to clients across various industries. With our expertise in composing and scrutinizing job descriptions, we ensure that our clients\' recruitment needs are met effectively. Role And Responsibilities We are currently hiring for the position of Officer / Executive- Drug Regulatory Affairs (API) for a leading pharmaceutical API manufacturing company based in Mandva, Gujarat. The selected candidate will be responsible for the following: Compilation and submission of Drug Master Files (DMFs) globally for new APIs in eCTD format and in-line with ICH and region-specific regulatory guidelines (EU, US, Canada, Australia, Brazil, China, South Korea, etc.). Compilation and submission of amendment to existing DMFs globally in eCTD format and in-line with ICH and region-specific regulatory guidelines (EU, US, Canada, Brazil, etc.). Compilation of response to queries received from Regulatory Agencies and submission of response within the stipulated timeline. Assessment of change proposals from a regulatory perspective. Keeping updated on current regulatory guidance. Coordinating with cross-functional teams for the review and collection of filing requirements. Providing the Applicant\'s Part of DMFs to customers as per customer/business requirements. Providing timely responses to DMF review comments given by customers and providing support to customers for appropriate and timely responses to regulatory deficiencies to expedite the approval process. Providing inputs/comments in the finalization of drug substances, intermediates, and starting materials specifications. Following up with stakeholders and reviewing documents received from cross-functional teams. Candidate Qualifications To be considered for this position, candidates must meet the following qualifications: M.Sc. or B. Pharm/M.Pharm. 2-6 years of relevant experience in filing API DMF. Aptitude for learning new responsibilities. Proficiency in Adobe Acrobat, Microsoft Word, Microsoft Excel, and Microsoft Presentation. Knowledge of current regulatory requirements for regulated and ROW markets, as well as ICH guidelines. Knowledge of evaluation and control strategy of impurity profile for new products. Familiarity with eCTD. Required Skills The ideal candidate should possess the following skills: Proficiency in strategic planning and execution. Strong leadership abilities, with a passion for empowering teams. Excellent negotiation and relationship-building skills. A results-driven mindset with unwavering focus on targets. Why This Role Matters This role is crucial as the selected candidate\'s contributions will chart our business course and shape the pharmaceutical industry landscape. Career Pathway We offer an upward career trajectory with opportunities to lead and excel within our organization. Skills: microsoft presentation,pharma api,ros evaluation and control strategy,api dmf,compilation of response to queries,regulatory affairs

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