CMC Regulatory Manager Biotechnology Remote

5 days ago

Budapest, Budapest, Hungary Carbyne Full time €80,000 - €120,000 per year
Our internationally recognized pharmaceutical partner is seeking an experienced and driven CMC Regulatory manager to play a key role in the development and regulatory strategy of their biotechnological products. This strategic position offers the opportunity to contribute to high-impact, globally recognized projects in an innovation-driven pharmaceutical environment.

The role is remote-friendly with the option to work from our Budapest headquarters or remotely within the EU. 

Key Responsibilities:

  • CMC Documentation Preparation and Submission: Author, review, and deliver high-quality CMC dossiers within defined timelines.

  • Regulatory Strategy Development: Design effective CMC regulatory strategies for clinical trial materials and marketing authorization procedures worldwide.

  • Lifecycle Management: Manage variations and post-approval activities for marketed products, ensuring timely and compliant submissions.

  • Regulatory Guidance: Provide strategic input across multiple projects, identifying regulatory challenges and offering expert solutions.

  • Health Authority Communication: Lead discussions and negotiations with regulatory agencies to facilitate approvals.

  • Interpretation of Regulatory Documents: Advise manufacturing, quality, development, and comparability teams on regulatory impact.

  • Compliance Strategy: Deliver proactive, efficient, and strategic regulatory compliance advice.

  • Independent Decision-Making: Solve complex tasks and make high-level decisions autonomously.

  • Risk Management: Identify, resolve, and communicate regulatory risks and mitigation strategies.

  • Cross-Functional Collaboration: Actively participate in multidisciplinary teams to define regulatory submission content.

Your Profile:

  • MSc degree in Life Sciences or relevant scientific field (e.g. Biochemistry, Biology, Chemistry, Pharmaceutical Technology)

  • Minimum 3 years of experience in CMC regulatory affairs for biotechnological products

  • Solid knowledge of EU, US, and ROW regulatory frameworks

  • Strong understanding of GMP for biotech medicinal products

  • Expertise in biologics, recombinant molecules, and biosimilars

  • Experience with document management systems and CTD publishing software

  • Excellent written and spoken English skills

What our partner offers:

  • Strategic role in an innovation-driven biotech department

  • Stable and trusted workplace at a globally respected pharmaceutical company

  • Multidisciplinary team collaboration and international projects

  • Competitive senior-level compensation package

  • Company car + performance-based bonuses

  • Remote work option -  office presence required only a few days per month

  • Training and professional development opportunities

  • Private medical services and life insurance, wellness and sport programs

    Should you be interested in the opportunity please do not hesitate to submit your professional CV so we can contact you with the further details.

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