CMC Lead - biotech expert 1

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 . We are looking for applicants from all over the world.

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 collegues

What You’ll Bring

• At least a MSc in life science or relevant scientific field (e.g. Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering)
• 8+ years of experience in the biotech industry, with demonstrated experience in the biotechnological regulatory CMC and/or Health authorities
• Strong knowledge of current relevant regulations; US, EU, APAC and ROW experience an asset
• Strong knowledge of cGMP
• Experience with eCTD format and content regulatory filings
• Strong result-oriented and problem solving mindset
• Good influencing, negotiation and relationship management skills
• Ability to establish common ground with stakeholders, balancing out conflicting interests and reaching consensus
• Positive, open mind and willingness to keep learning every day. Growth mindset, a “can-do” attitude
• Able to effectively manage with a high sense of urgency without compromising quality
• Very good written and oral communication skills

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