8 beste Stellen als scientific expert in frankfurt am main, he – aktuell auf Personalsuche

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scientific expert jobs near frankfurt am main, he

Associate Director Global Regulatory Affairs (m/f/d)

Otsuka Pharma -
Frankfurt am Main

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Details zur Stelle

Qualifikationen

Microsoft Powerpoint
Microsoft Word
Microsoft Excel
Microsoft Outlook
Englisch
Microsoft Office
Präsentationserfahrung
Pharmazie
PC-Kenntnisse

Vollständige Stellenbeschreibung

Jobbeschreibung

We are seeking a highly experienced and strategically driven Associate Director of Regulatory Affairs to lead and support the development and execution of global regulatory strategies across complex development programs. This role offers an excellent opportunity for a regulatory professional with strong European expertise and broad global exposure to contribute to the advancement of innovative medicinal products through all stages of development and registration.

The successful candidate will play a pivotal role in shaping and implementing regulatory strategies across multiple geographies, with a particular focus on Europe. Lead and support the development and execution of global regulatory strategies for development-stage and marketed products. Provide strategic input across key regulatory activities, including initial MAA, ODD, Scientific Advice, and PIPs, while acting as a primary interface with the EMA and other health authorities. Drive regulatory planning for major development milestones and market expansion, partnering cross-functionally to ensure aligned execution, effective risk management, and lifecycle optimization

Providing strategic regulatory guidance developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and managing lifecycle regulatory activities in alignment with the Therapeutic Area Lead under the direction of the Senior Director or Executive Director or Head of Region Europe

Ensuring the primary contact to Competent Authorities within Europe and other regions as required
Identifying the need and obtaining regulatory intelligence, researching precedent approvals and prior health authority decisions to assess applicability to support development of strategic options for assigned Otsuka products
Translating complex pertinent global requirements and providing an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed
Leading a cross functional team to collaboratively develop a global regulatory plan, address global regulatory issues, respond to health authority queries, and meet regulatory obligations including a focus on European requirements as needed per responsibility
Developping and leading strategy for Health Authority interactions/communications through submissions and responding to regulatory authorities within company timelines and in accordance with regulations and guidelines
Reviewing submission documents to ensure they are aligned with the strategic approach developed by the cross functional team
Designing programs for complete and accurate IND/CTA/NDA/MAA and other submissions and ensuring that clinical trials are designed to meet regulatory requirements
Supporting development of strategies, drafts responses, and/or reviewing responses and documents intended for submission to health authorities to assure compliance with regulatory standards
Reviewing submission documents for consistency and ensuring they are aligned with strategic approach developed by the team
Interacting with regulatory agencies and ensuring conversations and communications are focused, amicable and documented
Contributing to the submission of product registration of new drugs, progress reports, supplements, amendments, aggregate reports and periodic adverse experience reports
Collaborating and providing oversight to outsourced suppliers of regulatory support in the preparation of documents/reports
Identifying early major regulatory issues and ensures these are communicated to relevant stakeholders in a timely manner

Stellenanforderungen

Comprehensive knowledge of the drug development process, drug laws, global regulations, and guidelines
Good understanding of the global regulatory agencies
Experience leading submission of CTA, IND, sNDA/NDA/MAA/Variations
University degree in Medicine, Pharmacy, Life Sciences or Chemistry
Several years of clinical/industry/health authority or otherwise relevant experience, preferably in a global or at least European role.
Good CMC knowledge
Experience in one or more of the therapeutic fields: Oncology, CNS, Cardio-Renal
Strong information searching, summarization and assessment skills
Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
Strong analytical skills and problem solving ability
Strong communication and presentation skills with an excellent command of the English language
Experience in working in, and communicating with cross-functional, multi-cultural project teams involving internal and external experts.
Strong knowledge and experience in European Regulatory Affairs encompassing strategic and operational aspects

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scientific expert Jobs in frankfurt am main, he

Associate Director Global Regulatory Affairs (m/f/d)

Director - Health, Safety & Environment

Trainee Technischer Vertrieb (Industrial - Paper)

IT-Consultant m/f/d

Business Development Manager

IT Consultant mit Schwerpunkt Interfaces m/w/d

System Engineer

European Inside Sales Team Leader, Biopharm

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