Regulatory Lead, Marketed products
vor 4 Wochen
The Global Regulatory Affairs Lead (Oncology – Marketed Products) is responsible for developing and executing global regulatory strategies to support the lifecycle management of marketed oncology products. This role provides strategic and operational regulatory leadership across multiple regions, ensuring continued compliance, label optimization, and product maintenance in alignment with business objectives and evolving regulatory requirements. The successful candidate will serve as the primary global regulatory point of contact for assigned oncology products, partnering cross-functionally with regional affiliates, clinical development, safety, medical affairs, and commercial teams to ensure that regulatory deliverables are met and that patient access is maintained worldwide. Key Responsibilities Strategic Leadership Lead global regulatory strategies for marketed oncology products, including variations, line extensions, labeling updates, and post-approval commitments. Provide strategic input into lifecycle planning, including risk assessments and regulatory intelligence for oncology indications. Serve as the global regulatory representative on cross-functional product teams, driving regulatory excellence and proactive compliance. Compliance and Intelligence Monitor and interpret global oncology regulatory trends, guidelines, and legislation impacting marketed products. Ensure ongoing compliance with global regulatory requirements and internal SOPs. Drive continuous improvement in regulatory processes, systems, and cross-functional collaboration. Stakeholder Management Build and maintain strong partnerships with internal stakeholders (e.g., Quality, CMC, Medical Affairs, Commercial) and external partners (e.g., regulatory consultants, alliance partners). Provide expert regulatory advice to senior management on potential impacts of regulatory changes and opportunities for optimization. Qualifications and Experience Education: Advanced degree in life sciences, pharmacy, or a related discipline (PhD, PharmD, or MSc preferred). Experience: Minimum 8–10 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry. Strong knowledge of global regulatory frameworks (FDA, EMA, ICH, PMDA, Health Canada, etc.) and oncology drug development lifecycle. Proven track record of successful regulatory submissions and interactions with major Health Authorities. Skills and Competencies: Strategic thinker with ability to balance scientific, technical, and business perspectives. Excellent leadership, communication, and negotiation skills. Ability to manage multiple complex projects across geographies and time zones. Strong analytical, organizational, and problem-solving abilities. High level of integrity, accountability, and cross-functional collaboration.
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Regulatory Lead, Marketed products
vor 4 Wochen
Deutschland Discover International VollzeitThe Global Regulatory Affairs Lead (Oncology – Marketed Products) is responsible for developing and executing global regulatory strategies to support the lifecycle management of marketed oncology products. This role provides strategic and operational regulatory leadership across multiple regions, ensuring continued compliance, label optimization, and...
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Team Lead Regulatory CMC Writing
Vor 4 Tagen
Alfred-Wegener-Straße , Frankfurt am Main, Deutschland Merz Therapeutics Vollzeit 80.000 € - 120.000 € pro JahrYOUR CONTRIBUTIONAs a Team Lead Regulatory CMC Writing (m/f/d), you will be the central contact point for our manufacturing site for development and maintenance of regulatory documentation to support creation of actual regulatory dossiers. This will include the following activities:Preparation of CMC documentation in compliance with internal requirements...
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German Speaking Product Consultant
vor 3 Wochen
Deutschland Vivo Talent Solutions VollzeitGerman-Speaking Product Consultant – Banking Sector (Recovery & Collections) Location: Germany – remote We’re looking for a native or fluent German-speaking Product Consultant with deep expertise in German banking, specifically collections, recovery, and restructuring. This client-facing role focuses on functional advisory, regulatory guidance, and...
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Global Regulatory Affairs
Vor 6 Tagen
Deutschland Grolman Group Vollzeit 60.000 € - 80.000 € pro JahrYour tasks: Adhering to and ensuring legal compliance in the area of chemicals law Working according to the principles of product stewardship in the area of food contact materials, toys and cosmetics etc.Ensuring compliance with various export regulationsPlausibility check of safety data sheetsProduct notifications according to § 45 CLP-VO as well as...
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Staff Product Manager
vor 3 Wochen
Deutschland DiscoverCars.com Vollzeit 3.500 €🔊We’re looking for a Staff Product Manager - Insurance Innovation & Ancillary Products. Join DiscoverCars.com and help us scale the world's leading global car-rental marketplace. We're seeking a visionary Staff Product Manager to lead our Insurance Innovation & Ancillary Products domain, driving the strategy and execution of innovative products that...
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Manufacturing Lead, EU GMP Operations
vor 3 Wochen
Deutschland BioTalent VollzeitManufacturing Lead, EU GMP Operations PLEASE NOTE: Applicants must be fluent in both German and English and currently based in Germany . You must also have hands-on experience with commercial medicinal products and/or IMPs across solid, liquid, and ideally sterile manufacturing, along with a solid understanding of EU importation and QP release standards....
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Director Product Supply
vor 2 Wochen
Deutschland Discover International VollzeitWe're supporting an innovative and fast-scaling biotech company in Germany in their search for a Director of Product Launch & Supply Chain. This is a critical leadership role responsible for driving end-to-end launch readiness and global supply chain strategy across a pipeline of cutting-edge therapies. Key Responsibilities: Lead cross-functional product...
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Fraud Product Manager
Vor 4 Tagen
Deutschland Nexi Germany GmbH Vollzeit 90.000 € - 120.000 € pro JahrShape the Future of Payments with Nexi in 2025Envision a world where every transaction feels effortless, safe, and connected. At Nexi, we're leading this transformation, building tools and solutions that redefine how the world pays. By joining us, you'll play a part in creating the next generation of digital payments in an innovative, supportive, and...
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Product Development Manager
Vor 7 Tagen
Deutschland Vanatari VollzeitAbout Vanatari At Vanatari, we develop high-quality, 100% vegan supplements rooted in scientific evidence and built on transparency and integrity. Our core brand, Vegavero, stands for the belief that true health starts with nature. With wowtamins, our newest brand, we support parents in promoting healthy nutrition habits for their children. ...
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Founding Product Marketing Lead
Vor 7 Tagen
Deutschland Propel VollzeitFounding Product Marketing Lead | Climate-Tech App | Remote (Europe-based) We’re partnering with a fast-growing climate-tech startup on a mission to make climate action part of everyday life. Their consumer app has already attracted tens of thousands of users globally and they’re just getting started. With founders that have previously scaled 2x unicorns...
