Sr. Principal Consultant, Regulatory Strategy and Advisory
Vor 6 Tagen
All candidates should have a passion for helping our clients navigate transformational change; We are looking for smart, self-driven, high-energy people with top-notch communication skills, intellectual curiosity. The Candidate should have a rare blend of industry domain, process, technical and consulting skills. Industry domain expertise can be in one or more areas of Life sciences. Consulting skills should entail client relationship management, effective executive communication, critical thinking in a consultative approach with our clients. Additional skills that are highly desirable include value realization, process re-engineering, design thinking and agile delivery experienced Role Summary, Core Expectations In depth knowledge of Pharma Regulatory Operations and Regulatory IT Systems aligned to core Functional and Technical competencies Expert in Regulatory and Clinical area with ability to drive futuristic IT solutions and experience in client facing and agency thought leadership. Understanding and knowledge of processes related to health authority submissions, content authoring, labeling, lifecycle management of CMC, regulatory intelligence, and country-specific regulatory requirements – keenly aware of industry trends, needs and business requirements expected from clients Able to strategize and advise on the product roadmap and should work closely with the client in delivering solutions. An empathic people manager responsible to mentor and guide a team for progressive outcomes Technical Credentials: Should have master’s degree in a Life Science, Medical or Related discipline. Master’s in Business Administration would be an added advantage. Minimum 12-15 years’ experience in Drug development, Regulatory, Clinical Operation and Medical Devices. Deep understanding of RIM systems i.e., Veeva Vault, PARAXEL/LIQUENT InSight, CSC Regulatory Tracker, ArisGlobal Register, OpenText, SharePoint, Documentum, FirstDoc / FirstPoint, NextDocs, CARA, Extedo eCTD Manager, Trackwise, or other regulatory information management systems Submission and publishing tools. Knowledge of regulatory IT systems landscape and implementation experience inclusive of integration and Migration aspects Responsibility of / Expectations from the Role: Work with Business Regulatory experts and IT Experts globally to analyze, develop, and implement Regulatory processes and provide solutions to business problems and support business in implementing innovative Regulatory Platform solutions, in the most agile ways of working. Design innovative product features based upon industry requirements for Health Authority submission management, content authoring, labeling, regulatory intelligence, country-specific regulatory requirements, and emerging standards. Formulate recommendations for improvement in business processes and system configuration, developing user requirements to facilitate solutions to achieve the business vision and address key use cases. Coordinate with the implementation team across multiple phases and workstreams (e.g., solution design and configuration, systems integration, data migration, validation, and training). Primary customer liaison managing communication between the project team, customer, and internal stakeholders and vendors.
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Munich, Bayern, Deutschland Infosys Consulting - Europe Vollzeit 80.000 € - 120.000 € pro JahrAll candidates should have a passion for helping our clients navigate transformational change; We are looking for smart, self-driven, high-energy people with top-notch communication skills, intellectual curiosity. The Candidate should have a rare blend of industry domain, process, technical and consulting skills. Industry domain expertise can be in one or...
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Principal Consultant
Vor 5 Tagen
Munich, Bayern, Deutschland Alaika Advisory Vollzeit 120.000 € - 240.000 € pro JahrAt ALAIKA, we are building the future of Financial Services with a bold vision: to become the most specializedEnterprise Financial Services advisory & investment firm in the industry by coupling Fortune 500 board room access, the deepest Financial Services domain expertise with a global Venture Capital & Private Equity network.Through our three...
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Principal Consultant
Vor 5 Tagen
Munich, Bayern, Deutschland ALAIKA Advisory Vollzeit 120.000 € - 180.000 € pro JahrAt ALAIKA, we are building the future of Financial Services with a bold vision: to become the most specialized Enterprise Financial Services advisory & investment firm in the industry by coupling Fortune 500 board room access, the deepest Financial Services domain expertise with a global Venture Capital & Private Equity network. Through our three...
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Senior Strategy Consultant
Vor 7 Tagen
Greater Munich Metropolitan Area, Deutschland TTE Strategy Vollzeit 100.000 € - 125.000 € pro JahrTTE Strategy is an independent and multiple-award-winning, #1 boutique consultancy specializing in strategy and transformation. Founded in 2015, we advise and support clients around the globe on matters of strategy design and strategy delivery. We are based in Hamburg, Munich, Stuttgart and ZurichWE ARE LOOKING FOR:SENIOR STRATEGY CONSULTANT (m/f/d) in...
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Associate, Restructuring
Vor 7 Tagen
Munich, Deutschland Interpath Advisory VollzeitAssociate, Restructuring Interpath Munich or Frankfurt or Dusseldorf or Berlin or Vienna Interpath is an international and fast-growing advisory business with deep expertise in a broad range of specialisms spanning deals, advisory and restructuring capabilities. We deliver tangible results for global businesses, their investors, and stakeholders when complex...
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Associate, Restructuring
Vor 7 Tagen
Munich, Deutschland Interpath Advisory VollzeitAssociate, Restructuring Interpath Munich or Frankfurt or Dusseldorf or Berlin or Vienna Interpath is an international and fast-growing advisory business with deep expertise in a broad range of specialisms spanning deals, advisory and restructuring capabilities. We deliver tangible results for global businesses, their investors, and stakeholders when complex...
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Vice President Transaction Advisory
Vor 3 Tagen
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Principal Consultant Citrix
vor 2 Wochen
Munich, Deutschland Solvenio GmbH VollzeitBei Solvenio, einem führenden Unternehmen im Bereich der IT-Beratung, freuen wir uns, Ihnen die spannende Möglichkeit zu bieten, als Principal Consultant Citrix Teil unseres engagierten Teams zu werden. In dieser Rolle haben Sie die Chance, Ihre umfassende Expertise in Citrix-Lösungen einzubringen und innovative Strategien für unsere Kunden zu...
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Principal Consultant Citrix
vor 1 Woche
Munich, Deutschland Solvenio GmbH VollzeitBei Solvenio, einem führenden Unternehmen im Bereich der IT-Beratung, freuen wir uns, Ihnen die spannende Möglichkeit zu bieten, als Principal Consultant Citrix Teil unseres engagierten Teams zu werden. In dieser Rolle haben Sie die Chance, Ihre umfassende Expertise in Citrix-Lösungen einzubringen und innovative Strategien für unsere Kunden zu...
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Munich, Deutschland State Street Corporation VollzeitState Street Corporation Munich, GermanyPosted 16 hours ago Permanent Competitive - Sr. Information Security Officer, Managing Director - State Street Bank International GmbH ('SSBI') seeks to recruit a Senior Information Security Officer, Managing Director (Sr. ISO) to improve the overall protection of SSBI, its customers and partners from an evolving and...
