Senior Lead Regulatory CMC

This is a fully remote position, open to applicants in Germany.

📋 Description

• Develop and execute regulatory CMC strategies for designated products.

• Oversee all product-related Regulatory CMC activities within the portfolio to ensure timely implementation.

• Prepare, review, and maintain CMC documentation for regulatory submissions, including the creation of relevant regulatory justifications.

• Evaluate national and international requirements to guarantee regulatory compliance.

• Contribute to submission strategies and assist with modifications and further development of existing products.

• Analyze regulatory risks, particularly concerning variation procedures, and formulate suitable mitigation strategies.

• Collaborate closely with internal departments, international partners, and external service providers.

• Offer technical guidance to colleagues and participate in cross-functional improvement initiatives.

⛳️ Requirements

• Master's degree in pharmacy, chemistry, biology, or a related scientific field.

• Minimum of 7 years of professional experience in Regulatory CMC within the pharmaceutical sector.

• In-depth experience with CMC dossiers, regulatory submissions, and the lifecycle management of authorized medicinal products.

• Expertise in navigating national and international regulatory requirements.

• Proven track record in providing technical leadership for complex projects and managing cross-functional interactions.

• Experience in matrix or direct personnel management is advantageous.

• Strong strategic thinking abilities coupled with a structured and independent work style.

• Excellent communication skills for effective collaboration with internal teams and external partners.

• Proficient in both German and English languages.

🏝️ Benefits

• A significant role with the opportunity to influence processes in an international work setting.

• Flexible working arrangements, including remote work options.

• Working-time account with the possibility of time off in lieu.

• 30 days of annual leave.

• Tailored internal and external training and development opportunities.

• A flexible additional benefits budget.

• Access to an employee discounts platform.

• Company and team events.