Regulatory Affairs Manager

3 weeks ago

Gurgaon, Haryana, India Takeda Full time

By clicking the Apply button I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas and I further attest that all information I submit in my employment application is true to the best of my knowledge OBJECTIVES PURPOSETo lead and develop Regulatory strategies for New Products existing products and other pipeline molecules of Takeda in accordance with the applicable rules and regulations Responsible and accountable for local regulatory activities driven by local or corporate initiatives and peformances in registering new products and new indications The individual will execute all the regulatory activities related to Global Clinical Trials registration requirements Renewals and products lifecycle maintenance for India and neighboring countries Sri Lanka Bangladesh Nepal as per Business needs To act in compliance with country policies and practices to reduce companys exposure to Regulatory risks Lead Development and Implementation of Regulatory Policy Advocacy Strategy Develop the policy content material Identify develop and produce policy materialTo build partnership with various regulatory agencies in India and to keep updated on changes to local and global regulatory environment trends and impact of the regulatory requirements changes to the local business opportunities EDUCATION BEHAVIOURAL COMPETENCIES AND SKILLS Bachelors in Pharmacy or Masters in Chemistry Sciences Biotechnology Biomedical Engineering Microbiology or equivalent degree Candidate should ideally have 08 -10 years of experience in Pharmaceutical Medical Device CRO industry In-depth knowledge of local regulations pertaining to product registration requirements for pharmaceutical products and understand its interpretation as well as Regulatory Corporate Policies Have or acquire overall understanding of the local business decision-making process that impacts the regulatory strategy Strong knowledge of relevant local regulations in handling Biological orphan drugsExcellent verbal written communication skillsProject managementStakeholder managementCustomer FocusCreative thinking and problem solvingAble to develop effective working relationships with HAs MoHIntegrity honesty perseverance fairnessBusiness partner mindsetAcceleration of Product registrations and licensesExternal stakeholder relationships managementDocumentationCross-functional collaborationResponsibilities1 Regulatory PlanningRegulatory Plan DevelopmentPlan review and recommend the best regulatory strategy for submissions including regulatory timelines during the planning phase for pipeline products of assigned portfolio based on regulatory expertise with country regulations MOH processes Manage and ensure the country Regulatory Plans are in alignment with Product Teams Area strategies and the countrys business plan 3 1 Process Managementi Coordinates the process with other functional members sites and corporate Legal Administration etc to ensure timely availability of required documents for dossier preparation ii Active participation in cross-functional teams within the local operating company LOC and provide regulatory expertise and insight to ensure regulatory timelines are met or improved Regulatory Toolsi Timely update of all databases as per LOC regulatory planii Ensure data is complete and accurate and that the updates meet or improve upon the established compliance metrics i e outstanding submissions approvals 2 Submissions and ApprovalsDossier PreparationPrepare a quality regulatory dossier and submit within the planned timelines Activities include Request and obtain the various regulatory items needed for the local submissionPrepare format the dossier to ensure it meets local requirementsImplement the submission and archive appropriatelyGain Regulatory ApprovalGain Health Authority approvals to meet product launch plans and ensure product maintenance Activities include Provide quality responses to the Health Authorities by due dateComplete regulatory approval process and gain product licensesCommunicate Product approvalArchive submission dossier and approval documentsTrack post approval commitment if anyPerform regulatory responsibilities related packaging developmentEnsure the local label creation and packaging development will meet local and corporate criteria and supports the business needsMetrics Reviewi Prepare periodic Regulatory Report of actual submissions and approval and communicate to local management ii Provide regulatory metrics on performance that are aligned with Area GEM Regulatory Affairs criteria to measure regulatory performance to LOC Area Regional management 3 Regulatory ComplianceCompliance Maintenancei Take appropriate actions to maintain all local marketed products in compliance with local and corporate regulatory requirements eg all aspects of labeling Product Information and packaging development label change management chemistry and manufacturing commitments that are registered with the DRA ii Conduct periodic compliance self-audit to identify potential compliance issuesiii Take corrective actions plans based on regulatory audit findingsGood Regulatory Practices GRP i Develop update and implement appropriate SOPs as required by the Global Regulatory Affairs policies Regulatory Quality Systems local regulations and acceptable Good Regulatory Practices 4 Regulatory InfluenceExternalRegulatory Customer RelationsEstablish relationship with key regulatory officials throughout direct interactions industry associations etc to influence regulators to foster positive regulatory environment for business and research Regulatory Environment ChangesKeep updated with current local regulations and DRA organizational structure and potential changes that will impact the business environment and communicate appropriately to involved or affected parties Influence StrategySupports the development and implementation of the established external regulatory influence strategy InternalLOC Organizationi Learn and understand the local organization and functions ii Build functional partnership and credibility to maximize regulatory value in support of business decisions iii Recognized as a valued member of decision making process that has or potentially has regulatory involvementLocationsIND - GurgaonWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Takeda

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