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Need now Senior Specialist License Management

4.00 to 9.00 Years   Bangalore   09 Jun, 2023
Merck Ltd
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

    Work Your Magic with us! Ready to explore, break barriers, and discover more We know you ve got big plans so do we! Our colleagues across the globe love innovating with science and technology to enrich people s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us.Derive project plan for regulatory deliverables e.g. Renewal Procedures, PSR submission, Variation applicationsAccountable for product license maintenance, strategy execution and operations for regional and local products closely aligned with the HQ FunctionManage and coordinate preparation of regulatory documentations to support regulatory submission activities (e.g. variations, renewals, answers to objections)Organize and coordinate the liaison with cross functional stakeholders in the dossier generation process for license management activities, incl. external partner(s)Support Module 1 preparation, as well provision of Certificates and StatementsSupport in authoring as adequateTrack submission roll-out & status, perform follow-ups & approval announcements, and maintain dossier lists to ensure regulatory compliance for all dossier submissions worldwidePerform quality checks and control for respective dossiersMaintain regulatory systems and data compliance (RIMS, CARA etc.)To provide any other ad-hoc support to activities executed at REC, envisaging that:-Relevant training has been successfully completed upfront-The necessary regulatory, system, product or process knowledge has been provided-Skills and competencies required for the ad-hoc tasks completion are in line with the agreed REC skill setSuch additional allocation may be an element of individual development plans or a contribution to the business continuity of the organisationPrepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet companys and health authorities requirementsEnable representatives from all major disciplines involved to reach agreement on the license management strategy and approachPosition will be working in a matrix organization, with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory AffairsThe role will have to work on complex tasks and to propose solutions and strategies as part of their day to day work What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! ,

Keyskills :
active directorytroubleshootingproduct compliancestrategy executionreachlistsdrives

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