Job Description

By clicking the xe2x80x9cApplyxe2x80x9d 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 Takedaxe2x80x99s and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job Title: Regulatory Affairs Lead, IndiaLocation: India, Gurgaon - HaryanaAbout the role:To lead and develop Regulatory strategies for existing products and other pipeline molecules of Takeda in accordance with the applicable rules and regulations.Responsible and accountable for local regulatory operations in the assigned therapeutic areas ensuring timely grant of new products registrations and license maintenance.Managing clinical trials from regulatory affairs perspective, ensuring earliest approval of clinical trial protocols to support global acceleration of new key assetsTo proactively anticipate and communicate changes in local regulatory landscape to the local and global leadership.To act in compliance with country policies and practices to reduce companyxe2x80x99s exposure to Regulatory risks.To build partnership with officials in Health Authorities and industry associations to be able to proactively participate in policy shaping and advocacy.To act as primary liaison with reg authorities on Takedaxe2x80x99s key RA projects in the countryTo support the country regulatory head in advancing skills of other team mates and elevate their capabilities through active engagement and other training engagements.How you will contribute:1. Regulatory Planninga) Regulatory 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 countryxe2x80x99s business plan (3/1).b) 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.c) 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 Approvalsa) Dossier 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 appropriatelyb) Gain 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 needsc) Metrics 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 Compliancea) Compliance 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 findingsb) Good Regulatory Practices (GRP)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 InfluenceExternala) Regulatory 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.b) 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.c) Influence StrategySupports the development and implementation of the established external regulatory influence strategy.Internala) LOC Organisationi) Learn and understand the local and regional 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 involvementWhat you bring to Takeda:SKILLS And COMPETENCIESBachelorxe2x80x99s in Pharmacy, Chemistry, Sciences, Biotechnology, Microbiology, or equivalent degree, masterxe2x80x99s degree in relevant subjects will be plusCandidate should ideally have 10+ years of experience in Pharmaceutical, Medical Device, CRO industry with at least 2+ years in managing a team of executivesIn-depth knowledge of local regulations pertaining to product registration requirements for pharmaceutical products and understand its interpretation as well as Regulatory Corporate PoliciesHave or acquire overall understanding of the local business decision-making process that impacts the regulatory strategyUnderstanding of relevant local regulations in handling Biological & orphan drugs (preferred)Excellent 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 collaborationCritical leadership capabilitiesProblem solvingManaging complexityLearning agilitiesSelf-awarenessCollaborationDrive for resultsMore about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.Empowering our people to shine:Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.Locations IND - GurgaonWorker Type EmployeeWorker Sub-Type RegularTime Type Full time

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