Senior Lead, Regulatory CMC

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

📋 Description

• Formulate and execute regulatory CMC strategies for designated products.

• Oversee all product-related Regulatory CMC activities within the portfolio and ensure prompt execution.

• Prepare, review, and sustain CMC documentation for regulatory submissions.

• Develop corresponding regulatory justifications.

• Evaluate national and international regulations to ensure compliance.

• Contribute to strategies for submissions.

• Assist with modifications and further enhancements of existing products.

• Analyze regulatory risks, particularly related to variation processes.

• Create suitable risk mitigation strategies.

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

• Offer subject-matter expertise to colleagues.

• Participate in cross-functional improvement initiatives.

⛳️ Requirements

• Master’s degree in Pharmacy, Chemistry, Biology, or a similar scientific field.

• A minimum of 7 years of experience in Regulatory CMC within the pharmaceutical sector.

• Comprehensive experience with CMC submissions, regulatory dossiers, and managing approved medicinal products.

• Strong understanding of national and international regulatory frameworks.

• Experience in providing functional leadership on complex projects and across various interfaces.

• Matrix or direct management experience is a plus.

• Ability to think strategically.

• Organized and self-motivated work approach.

• Excellent communication skills for collaboration with both internal departments and external partners.

• Proficient in both German and English.

🏝️ Benefits

• A significant role that allows for substantial influence and shaping within an international work environment.

• Flexible working options, including the possibility of remote work.

• Working-time account that includes 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 discount platform.

• Company-wide and team-specific events.