Manager of CMC Life-cycle Management

Position summary

We are looking for a highly skilled and motivated professional leader to lead our CMC Life-Cycle Management Unit within Regulatory Affairs. This is a key leadership role offering the opportunity to shape regulatory strategy, ensure compliance, and contribute to the success of our global product portfolio.

Key Responsibilities

• Lead the CMC Life-Cycle Management Unit, ensuring regulatory compliance across development projects, life-cycle management, and existing product portfolios. Manage and develop a high-performing team: delegate effectively, foster professional growth, and build a strong knowledge base in drug quality and regulatory science. Drive operational excellence by recognising strong performance, ensuring timely decision-making, and promoting innovation and change.

• Collaborate constructively with other departments, supporting cross-functional projects and ensuring alignment with company strategy.

• Oversee the preparation, review, and submission of high-quality CMC dossiers to support timely marketing authorisations, clinical trial applications, and change control processes.

• Provide strategic regulatory guidance for drug development projects, continuously monitoring international and local requirements.

• Represent the unit in internal and external meetings

Competencies

• Manages his/her team in a results-oriented manner that aligns with the company strategy, recognizing good performance and providing regular feedback.
• Can think and influence rationally, conceptually, and strategically, and step in when others cannot resolve.
• Works constructively with other units while embracing necessary conflicts to achieve the company's objectives.
• Good and assertive communication skills, delivering key messages effectively to various audiences at all levels.
• Decision-making makes timely and effective decisions, balancing the need for more information or analysis
• Expert in the CMC regulatory field, able to think systemically and align priorities with strategic goals
• Able to mobilize the team towards a common goal and provide labor supply.
• Open to changes and manages them effectively and proactively.
• System and process perspective, Quality mindset, Accuracy, precision, Reliability, Flexibility, Compliance, Self-development
• Setting an example to immediate colleagues by taking individual responsibility

Professional Qualifications

• At least a MSc in life science or relevant scientific field
• 5+ years of experience in Industry or at Health Authority in regulatory CMC 
• Robust understanding of CMC regulatory
• 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 consider as advantage

• Leadership experience