Senior Biotech CMC Manager

Responsibilities

• You will be accountable for authoring, review and delivery of the CMC dossiers with high quality standards and within portfolio defined timelines
• Develop/implement effective CMC regulatory strategies for clinical trial material and all marketing authorization procedure submissions worldwide
• You will be accountable for CMC-related Life-Cycle Management and post-approval activities (variations) of marketed products and for delivery of submission packages with high quality standards and within portfolio defined timelines
• Provide guidance for regulatory CMC aspects of finished products and development products in multiple projects; you identify regulatory drawbacks
• Develop, author and/or review documents to ensure that all submissions conform to health authority guidelines/expectations
• Drive internal and external (Health Authorities) 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 – advise Manufacturing, Quality, Process/Analytical Development and Comparability units regarding their applicability and impact on internal programs
• Providing high quality, proactive, strategic, effective and efficient healthcare compliance advice. Manage the development and discussion of the company strategy if needed
• Solve complex and high-responsibility tasks independently
• Make independent professional decisions in case of high complexity tasks
• Identify and proactively mitigate roadblocks
• Identify, solve and communicate regulatory CMC risk and key mitigations
• Participate as an (pro-)active member of multi-disciplinary teams, ensuring appropriate and effective communication to define content for regulatory submissions

Your profile

• At least a MSc in life science or relevant scientific field (e.g. Biochemistry, Biology, Chemistry, Chemical Engineering, Pharmaceutics with focus on protein chemistry)
• 3+ years of experience in Industry or at Health Authority in regulatory CMC of biotechnological products (Registration, Post-approval procedures, Clinical trial applications, Scientific Advices)
• 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 and biosimilars (synthetic peptides is a plus)
• Experience with document management systems and CTD publishing software. Knowledge of industry change control procedures/systems 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

We offer

• Great opportunity for professional development in an innovation driven department
• Great reputation at a well established pharmaceutical firm
• Stability and a trustworthy workplace
• Work in multidisciplinary teams
• Training and development opportunities
• Medical services and life insurance
• Various sport and health opportunities
• Excellent work life balance