CMC Regulatory Affairs Manager

About Us My client is a globally operating pharmaceutical company dedicated to delivering high-quality medicines and nutritional supplements. With a commitment to excellence, they ensure the products are manufactured, quality-checked, and approved to the highest standards. Nearly all of their offerings are produced in Germany, ensuring consistency and reliability across all markets. Join their team and help make a meaningful impact on global healthcare. Your Responsibilities:

• Manage approval processes for generic medicines in German and European markets.
• Lead new submissions and maintain regulatory approvals.
• Update and maintain quality dossiers in line with European guidelines.
• Collaborate closely with project management, quality assurance, and procurement teams.
• Address diverse challenges with flexibility and handle complex situations effectively.

• Degree in pharmacy, natural sciences, health economics, or a related field, or vocational training as PTA or PKA.
• At least 2 years of experience in drug regulatory affairs, preferably in CMC/Module 3, with knowledge of drafting DE official texts.
• Strong communication skills, team spirit, and enthusiasm for working in a multicultural environment.
• Precise, structured, and conceptual approach to tasks.
• Proficiency in German and English.
• High sense of responsibility, reliability, and independence.
• Previous experience as an information officer is an advantage.

• Work & Life : Flexible working hours, remote work options (up to 50%), and short Fridays.
• Connect & Grow : Team-building events such as summer festivals, holiday parties, and after-work gatherings.
• Feedback & Development : Regular feedback sessions, personal development discussions, and monthly surveys for continuous improvement.
• Personal Growth : Customized workshops for professional and personal development.
• Health & Wellness : Access to fitness and wellness programs (e.g., gyms, yoga, massages) and free nutritional supplements and healthy snacks.
• Buddy Program : Onboarding support and networking opportunities through a dedicated buddy system.
• Additional Perks : €150 shopping card, performance-related bonuses, exclusive discounts, company pension scheme, and more.