CMC Manager

Join us

We are seeking a highly motivated individual to join our CMC Regulatory Affairs team as CMC Lead for biotechnological products who will support the development, clinical and marketing authoring procedures (pre- and post-approval)  of biosimilar products for Gedeon Richter’s product portfolio.

The biotechnological CMC Lead will be responsible for preparing and overseeing CMC and Quality related agency correspondence and regulatory applications, as well as govern CMC submissions and regulatory compliance support. This position will contribute, manage, and support all regulatory activities to provide high quality CMC sections of regulatory documentation. The candidate will need to successfully manage projects independently in a fast paced, cross-functional matrix organization and  will be accountable for CMC Lifecycle Management of biotechnological products.

Development of CMC regulatory strategy for the products in our portfolio will be a key success component. Gedeon Richter plc is an innovation-driven specialty midpharma multinational company headquartered in Hungary.

What you'll do

• You will be accountable for the delivery of the CMC dossiers with high quality standards and within portfolio defined timelines. 
• Develop/implement effective CMC regulatory strategies for clinical trials and all marketing authorization procedure submissions worldwide.
• Provide guidance for regulatory CMC aspects of product in multiply projects; identify regulatory considerations.
• Develop, author and/or review documents to ensure that all submissions conform to health authority guidelines.
• Drive Regulatory CMC discussions and interactions to facilitate review and approval of submissions for all CMC aspects of the dossier.
• Provide interpretation of regulatory guidance documents, regulations and directives – advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs.
• Providing high quality, proactive, strategic, effective and efficient healthcare compliance advice. Manage the development of company strategy if needed.
• Plan and carry out your tasks independently.
• Solve complex and high-responsibility tasks independently
• Prioritize your tasks and reorganize them if needed.
• Make independent professional decisions in case of high complexity tasks.
• Identify and manage critical path activities and their interdependencies
• Identify and proactively mitigate roadblocks
• Identify, solve and communicate regulatory CMC risk and key mitigations
• Ensure best practice sharing
• Participate as an active member of multi-disciplinary teams, ensuring appropriate and effective communication to define content for regulatory submissions.
• Support the creation and maintenance of CMC submission templates
• Evaluate CMC change controls 
• Provide professional trainings to colleagues

What You’ll Bring

• At least a MSc in life science or relevant scientific field (e.g. Biochemistry, Biology, Chemistry, Chemical Engineering, Pharmaceutics with focus on protein chemistry)
• 2+ years of experience in Industry or at Health Authority in regulatory CMC of biotechnological products
• Good understanding of current regulations in EU, USA and ROW for (investigational) medicinal products
• Good understanding of current GMP for biotechnological medicinal products
• Robust understanding of biologics / recombinant molecules, biosimilars is a plus
• Experience with document management systems and CTD publishing software is a plus
• Positive, open-minded, curious, and eager to learn every day. Growth mindset, a “can-do” attitude
• Very good written and oral English communication skills

What we offer

You can work in a team of helpful colleagues, where we value supportive collaboration and thinking together. In addition, we offer
•    Challenging, responsible professional work
•    Opportunity for continuous development
•    Long-term employment in an innovative and secure workplace
•    Training and development opportunities
•    Medical services and life insurance
•    Various sport and health opportunities
•    Extensive benefits package