Regulatory Specialist QA R&D | Chemiker (m/w/d)
LTS LOHMANN Therapie-Systeme AG
Job Summary
As a Regulatory Specialist in the Quality Assurance R&D department, you will play a pivotal role in managing global regulatory activities and clinical trial approval processes for pharmaceutical products. Working within a contract manufacturing environment, your day-to-day responsibilities include preparing high-quality regulatory documentation, managing deficiency letters, and providing regulatory guidance to cross-functional development teams. You will also oversee change control processes, ensuring compliance with GMP standards, and support customer audits. This part-time position (up to 20 hours/week) is ideal for a detail-oriented professional looking to apply their expertise in a dynamic, global pharmaceutical service environment. You will benefit from a collaborative team culture and the opportunity to contribute to significant international development projects while ensuring strict adherence to global regulatory guidelines.
Required Skills
Education
Successfully completed degree in natural sciences (e.g., Pharmacy, Chemistry, or equivalent).
Experience
- Minimum 5 years of professional experience in the pharmaceutical industry
- Experience in Quality Management, specifically in Regulatory Affairs or Quality Assurance
Languages
Additional
- Part-time position (up to 20 hours/week), initially fixed-term for two years. Knowledge of 21 CFR Part 4, 210, 211, Medical Device Directive, and Medical Device Regulation required. Experience with AI in a regulatory environment is considered a plus.