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Senior Manager Regulatory Affairs

4 months ago

Mumbai, India Lifelancer Full time
About the role:Reporting to the Head of Regulatory Affairs, you will be a key member of the team which is responsible for providing strategic and operational regulatory support to project management on new divestment projects, technical transfer, CMOs, quality assurance and commercial departments. Our Regulatory Affairs Department has an ethos of continuous improvement, refining systems and creating efficiencies. This, along with the rapid growth of the business, leads to a varied and dynamic working environment.Main responsibilities duties:Leads the preparation of core dossiers and submissions for global roll outCompile submission documents including M3 dossier sections as necessary, justification documents and Product Information.In collaboration with global partners, consultancies, and distributors, outline global regulatory intelligence and form a global regulatory strategyIn collaboration with senior management and project strategy teams, develop and review global cross functional regulatory strategiesEnsure diligent reporting and progress updates on regulatory workload at weekly/bi-weekly internal regulatory meetingInterpret applicable regulations and guidelines for project team use; keep project team abreast of regulatory decisions, evolving regulatory requirements, risks and mitigation plansServe as a primary contact to the local health authority (HA(s), local consultancies/ distributors and internal stakeholders, to ensure timely and accurate submissionsFacilitate communication between the HA(s) and the project team; attend and generally lead agency meetings, if requiredCoordinate and solicit components of the submission from various functional areas, distributors and CMOsProactively identify project issues to the project team and support mitigation plansAttend cross functional meetings, vendor meetings and kick-off meetings as requiredMentor and/or manage other Regulatory Managers, Regulatory Associates and other junior level or administrative Regulatory staffMaintain a high level of professional expertise through familiarity with scientific literature and participation in training coursesOther responsibilities may include training employees; planning, assigning, and overseeing regulatory submissions

About you:Candidates with at least five years of regulatory generalist experience within a pharmaceutical company, CRO, CMO, or similar organization are likely to have the skills required to be successful in this role.

We are also looking for:Bachelors degree in science/health disciplineGreat IT skills including MS Word, Excel, Project, PowerPoint, and OutlookExpertise in regulatory submission structure and content (e.g., MAA, NDA)Expertise in artwork requirements and review in line with regulationsStrong knowledge of EU regulatory framework and guidelinesExperience in compliance and maintaining product life cycle databases and RIMs systemsAbility to effectively communicate with regulatory authoritiesAbility to independently present complex regulatory strategies with internal stakeholders and partnersAwareness of emerging markets submission rolloutsExpertise in writing scientific and technical documents, and strong attention to detail with proofreading materialsExcellent time management skills with demonstrated ability to juggle multiple competing tasks and demandsStrong organizational skills to establish priorities including scheduling and meeting deadlinesAbility to work successfully within cross-functional teamsExcellent professional communication skills, both written and verbalFluent English language (written and verbal) is required, and another language would be an advantage.Please use the below link for job application and quicker response.