Would you like to join an internationally active company in a future-proof industry? Due to our ongoing growth, we are offering a permanent position in a modern work environment surrounded by nature (01328 Dresden). As a Regulatory Affairs CMC Manager – Dossier Review & Lifecycle Management (m/f/d), you can expect challenging tasks, flexible work schedules, and attractive benefits for an optimal work-life balance.
Regulatory Affairs CMC Manager – Dossier Review & Lifecycle Management (m/f/d)
Dresden
Full or part-time
Permanent employee
Your chance with us
More than just a job
- A permanent position at a future-proof, internationally active company
- Flexible work schedules to help you balance family and career
- 30 days of vacation for relaxation
- 10 paid sick days for children to support your family
- Modern workplace (e.g., height-adjustable desks) in a green setting
- Company parking and e-charging options
- 3 days off for personal reasons
- Access to a diverse selection of attractive benefits via our ROTOP Benefits Portal
- Job-Rad and Jobticket for sustainable mobility
- Team-building company events to foster a strong sense of unity
- Diverse career and development opportunities and additional benefits
Your tasks
- Creation, maintenance, and review of CMC documentation for national and international regulatory approval processes as well as clinical trials, e.g., IMPDs
- Management of regulatory lifecycle management, particularly variations and renewals
- Coordination of regulatory projects and close collaboration with internal departments, CDMOs, and sales partners
- Review of GMP-relevant documents and evaluation of changes in the manufacturing and quality environment
- Active support in the development, coordination, and implementation of regulatory strategies
- Ensuring structured and timely handling of regulatory requirements in the CMC environment
Your profile
- Bachelor’s or higher degree in a science-related field, e.g., pharmacy, chemistry, biology, biotechnology, or comparable
- Initial professional experience in the field of Regulatory Affairs
- CMC knowledge is desirable
- Knowledge of the CTD structure, particularly Module 3, as well as experience in the creation and maintenance of dossiers, is an advantage
- Strong communication and organizational skills, as well as the ability to work independently
- Enjoyment of interdisciplinary collaboration with internal and external stakeholders
- Very good written and spoken German and English
Your team
Join a growing team and help shape the future with us! Apply now for the position of Regulatory Affairs CMC Manager – Dossier Review & Lifecycle Management (m/f/d) and seize the opportunity to advance your career in a modern and international environment.
If you’d like to apply your skills in an innovative environment and further your personal development, we look forward to receiving your application. Please send it via email to bewerbung@rotop-pharmaka.de, attn: Sven Schäfer, or apply directly online.
About us
We are ROTOP Pharmaka GmbH, a leading pharmaceutical manufacturer in Germany, headquartered in Dresden-Rossendorf. For more than 25 years, we have developed, manufactured, and supplied cGMP-compliant radiopharmaceuticals for diagnostics and therapy in nuclear medicine and molecular imaging – distributed to more than 40 countries worldwide.
The ROTOP brand stands for quality, reliability, and pharmaceutical expertise. As a radiopharmaceutical manufacturer, we focus on close customer relationships, collaborative partnerships, and tailored radiopharmaceutical solutions for hospitals, clinics, and research partners. Our mission: advancing the medicine of tomorrow – developed and manufactured with responsibility.
ROTOP Pharmaka stands for integrity, expertise, and commitment – from Dresden to the future of nuclear medicine.
The ROTOP brand stands for quality, reliability, and pharmaceutical expertise. As a radiopharmaceutical manufacturer, we focus on close customer relationships, collaborative partnerships, and tailored radiopharmaceutical solutions for hospitals, clinics, and research partners. Our mission: advancing the medicine of tomorrow – developed and manufactured with responsibility.
ROTOP Pharmaka stands for integrity, expertise, and commitment – from Dresden to the future of nuclear medicine.