We're hiring API - Regulatory Affairs professionals!
Join us to drive global DMF submissions, regulatory compliance, and strategic market access.
Apply 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.
Regulatory Submissions & DMF Management :
Prepare, review, and submit Drug Master Files (DMFs) in compliance with global regulatory requirements and Manage full DMF lifecycle including amendments, annual updates, and variationsEnsure timely submission of regulatory dossiers and responses to health authoritiesMaintain accurate tracking and documentation of DMFs, LOAs, and deficiency responsesTechnical Evaluation & Documentation :
Evaluate route of synthesis, impurity profiling, and control strategiesReview process validation, analytical validation, and development dataDefine and justify Key Starting Materials (KSMs) for filingsDevelop specifications aligned with pharmacopeial and regulatory standardsQuery Handling & Compliance :
Draft and review responses to regulatory and customer queriesAddress post-approval changes and deficiency letters effectivelyEnsure accuracy, completeness, and compliance of submissionsCross-functional Collaboration :
Work closely with R&D, QA, QC, ADL, and API Manufacturing teams for dossier compilationCoordinate documentation for regulatory submissions and filingsSupport regulatory inspections and customer auditsStrategic & Operational Excellence :
Develop regulatory strategies to accelerate submissions and approvalsOptimize query response timelines and enhance regulatory processesProvide strategic inputs to meet registration and commercialization targetseCTD & Digital Expertise :
Handle global eCTD submissions using regulatory toolsEnsure compliance with evolving electronic submission standardsTroubleshoot submission-related technical issuesRequired Skills & Competencies
Technical Expertise :
Strong knowledge of global regulatory guidelines (USFDA, EMA, etc.)Hands-on experience in DMF compilation and lifecycle managementFamiliarity with pharmacopeial standards and updatesExpertise in eCTD submission platformsBehavioral Attributes :
Strong analytical and problem-solving skillsEffective written and verbal communicationStakeholder management and cross-functional coordinationAbility to manage multiple priorities in a dynamic environmentStrong decision-making and negotiation skillsHigh ownership and accountabilityStrong collaboration across multiple manufacturing sites and R&D teamsQualification & Experience
Masters in Science - M.Sc. (Mandatory)5+ years of experience in API Regulatory AffairsProven experience in global eCTD submissionsJob Responsibilities:
Core Competencies
Drive for Results - Can be counted on to meet goals successfully; is constantly and consistently one of the top performers.Action Oriented - Gets thing done, whether alone or through other people; makes good on commitments and ensures that others do; does whatever is required for a project and follows through.Time Management Able to plan and prioritise workload in order to meet deadline and achieve set goalsCustomer Focus - Keeps customers in mind at all times and strives to address customer needs. Assists business partners and customers achieve their work goals via application of their own skills and knowledge; strives to provide consistent customer satisfaction.Relevant Professional / Educational Background, Skills & Experience:
Part Qualified Accountant (CA / CMA)4-8 years experience working in a multi-national manufacturing company, preferably in Pharma/FMCG industryHands with JDE and SAP ERP environmentExcellent numerical and spreadsheet skillsStrong communication and interpersonal skillsCapable of working on own initiativeTeam player demonstrating maximum flexibility as required to complete key tasks Read LessSFE:
Launch and standardize the in-house SFE platform across key markets in collaboration with India SFE & IT teamsUnderstand CRM & FFR structures across key markets and streamline FF operations across EMStandardize & implement SFE metrics tracking across key EM countries (Customer coverage/ Class coverage/ Call Average/ Call frequency match/ PCPM/ Brand matrix/ Brand exposure/ Samples & input utilization/ etc)Lead the Digital transformation, automation and process improvement initiatives across key marketsDevelop a centralized SFE and Customer master databaseLead planning, controlling and monitoring of projects with CRM vendors across key marketsBuild MIS and dashboards on FF operations and SFE metrics for management reviews in collaboration with Country teams.Commercial Excellence:
Design structured field Incentive plans with a tailored market specific approach and monitor implementation for maximum sales impactCompile and track the Secondary Sales progress across key markets and channelsDesign standard Business review formats and follow-up on action points closure post reviewsBuild centralized Dashboards on Pri & Sec sales trends/ GC/ EBITDA/ etc for management reviewTrack the progress and drive KPIs for key Go-to-Market initiatives and projects across EMCore Competencies
Minimum of 7-10 years' experience in SFE &/or Commercial excellence roles in Pharma industryExperience rolling out SFE platforms, digital transformation and strong understanding of CRM systemsAdvanced proficiency in market data analysis models and analytical tools like Power BI, MS Excel, Tableau, etc.Business orientation, critical thinking, data visualization ability, working with multiple datasetsAbility to collaborate with cross-functional stakeholders & drive execution of agreed deliverablesStrong interpersonal communication and presentation skills Read LessWe're hiring API - Regulatory Affairs professionals!
Join us to drive global DMF submissions, regulatory compliance, and strategic market access.
Apply 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.
Regulatory Submissions & DMF Management :
Prepare, review, and submit Drug Master Files (DMFs) in compliance with global regulatory requirements and Manage full DMF lifecycle including amendments, annual updates, and variationsEnsure timely submission of regulatory dossiers and responses to health authoritiesMaintain accurate tracking and documentation of DMFs, LOAs, and deficiency responsesTechnical Evaluation & Documentation :
Evaluate route of synthesis, impurity profiling, and control strategiesReview process validation, analytical validation, and development dataDefine and justify Key Starting Materials (KSMs) for filingsDevelop specifications aligned with pharmacopeial and regulatory standardsQuery Handling & Compliance :
Draft and review responses to regulatory and customer queriesAddress post-approval changes and deficiency letters effectivelyEnsure accuracy, completeness, and compliance of submissionsCross-functional Collaboration :
Work closely with R&D, QA, QC, ADL, and API Manufacturing teams for dossier compilationCoordinate documentation for regulatory submissions and filingsSupport regulatory inspections and customer auditsStrategic & Operational Excellence :
Develop regulatory strategies to accelerate submissions and approvalsOptimize query response timelines and enhance regulatory processesProvide strategic inputs to meet registration and commercialization targetseCTD & Digital Expertise :
Handle global eCTD submissions using regulatory toolsEnsure compliance with evolving electronic submission standardsTroubleshoot submission-related technical issuesRequired Skills & Competencies
Technical Expertise :
Strong knowledge of global regulatory guidelines (USFDA, EMA, etc.)Hands-on experience in DMF compilation and lifecycle managementFamiliarity with pharmacopeial standards and updatesExpertise in eCTD submission platformsBehavioral Attributes :
Strong analytical and problem-solving skillsEffective written and verbal communicationStakeholder management and cross-functional coordinationAbility to manage multiple priorities in a dynamic environmentStrong decision-making and negotiation skillsHigh ownership and accountabilityStrong collaboration across multiple manufacturing sites and R&D teamsQualification & Experience
Masters in Science - M.Sc. (Mandatory)5+ years of experience in API Regulatory AffairsProven experience in global eCTD submissions