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Expert Licence Management

4.00 to 9.00 Years   Bangalore   14 Mar, 2022
Merck Ltd
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

    The Expert Licence Management prepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet companys and health authorities requirements. Encounter the challenges to enable representatives from all major disciplines involved to reach agreement on the license management strategy and approach.Position will be working in a matrix organization, with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs. The role will have to work on complex tasks and to propose solutions and strategies as part of their day to day work.Who You Are: Experience: Minimum 9 years of overall work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role. Minimum 3 years of Regulatory affairs experience.Education: Degree in a Life Science, Medical, PharmD or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)Job Specific Competencies & Skills: Ability to contribute to the dossier content and to perform content and quality review on regulatory documentationAbility to develop and prepare successful regulatory strategies and dossiersExperience in preparation and management of regulatory documentation, normally a full international submission (new product application) or large variationsExperience with life-cycle management activities in at least two regions (e.g. Europe, USA, International would be an asset)Solid experience in Regulatory Affairs regulatory dossiers and regulatory procedures on a global scale, including submission/registrations types and related requirementsIn Depth knowledge in Regulatory Affairs and experience of working in a global regulatory environment including exposure to registration procedures (CP, MRP, DCP, National etc.) and LCM strategiesAbility to review and interpret country specific and international regulatory guidelines, policies and regulations to generate submission ready deliverables as per requestStrong project management and documentation skills, proactive communication approachAbility to execute appropriate risk assessment and mitigation in cooperation with line manager /team leadAbility to provide Regulatory expertise into the planning and execution of projects and tasksAbility to work within a matrix organisation, build relationships with internal or external stakeholderContributor level experience with RIM and EDMS RA applicationsExcellent written and spoken communication skills and English language knowledgeJob Location: Electronic City Phase 1 - BangaloreWe have several openings for License Management roles for various levels and profiles Expectations and scope of responsibilities provided in this Job posting are for Specialist level The exact designation to be offered will depend on applicants experience and knowledge confirmed during the screening process ,

Keyskills :
environmental impact assessmentrisk assessmentproject managementtherapeutic areasposting

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