CMC Regulatory Manager Biotechnology Remote

Budapest - Hungary

Monthly Salary: Not Disclosed

Posted on: 8 hours ago

Vacancies: 1 Vacancy

Job Summary

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 theoption 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.

Required Experience:

Manager

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 rec...

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 theoption 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.