Regulatory Affairs Executive

We’re hiring API - Regulatory Affairs professionals !\nJoin us to drive global DMF submissions, regulatory compliance, and strategic market access.\n\nApply now and grow with a high-impact team. We are seeking a dynamic and detail-oriented professional to manage end-to-end regulatory submissions and lifecycle activities for API dossiers across global markets. The role plays a critical part in ensuring timely approvals, regulatory compliance, and seamless coordination across functions.\n\nRegulatory Submissions & DMF Management :\nPrepare, review, and submit Drug Master Files (DMFs) in compliance with global regulatory requirements and Manage full DMF lifecycle including amendments, annual updates, and variations\nEnsure timely submission of regulatory dossiers and responses to health authorities\nMaintain accurate tracking and documentation of DMFs, LOAs, and deficiency responses\nTechnical Evaluation & Documentation :\nEvaluate route of synthesis, impurity profiling, and control strategies\nReview process validation, analytical validation, and development data\nDefine and justify Key Starting Materials (KSMs) for filings\nDevelop specifications aligned with pharmacopeial and regulatory standards\nQuery Handling & Compliance :\nDraft and review responses to regulatory and customer queries\nAddress post-approval changes and deficiency letters effectively\nEnsure accuracy, completeness, and compliance of submissions\nCross-functional Collaboration :\nWork closely with R&D, QA, QC, ADL, and API Manufacturing teams for dossier compilation\nCoordinate documentation for regulatory submissions and filings\nSupport regulatory inspections and customer audits\nStrategic & Operational Excellence :\nDevelop regulatory strategies to accelerate submissions and approvals\nOptimize query response timelines and enhance regulatory processes\nProvide strategic inputs to meet registration and commercialization targets\neCTD & Digital Expertise :\nHandle global eCTD submissions using regulatory tools\nEnsure compliance with evolving electronic submission standards\nTroubleshoot submission-related technical issues\n\nRequired Skills & Competencies\n\nTechnical Expertise :\nStrong knowledge of global regulatory guidelines (USFDA, EMA, etc.)\nHands-on experience in DMF compilation and lifecycle management\nFamiliarity with pharmacopeial standards and updates\nExpertise in eCTD submission platforms\n\nBehavioral Attributes :\nStrong analytical and problem-solving skills\nEffective written and verbal communication\nStakeholder management and cross-functional coordination\nAbility to manage multiple priorities in a dynamic environment\nStrong decision-making and negotiation skills\nHigh ownership and accountability\nStrong collaboration across multiple manufacturing sites and R&D teams\n\nQualification & Experience\nMasters in Science - M.Sc.