Would you like to join an internationally active company in a future-proof industry? Due to our continuous growth, we are offering a permanent position in a modern work environment surrounded by nature (01328 Dresden). As Head of Regulatory Affairs – Pharmaceutical Approval (m/f/d), you can expect challenging tasks, flexible work schedules, and attractive benefits for an optimal work-life balance.
Head of Regulatory Affairs – Pharmaceutical Approval (m/f/d)
Dresden
Full or part-time
Permanent employee
Your chance with us
More than just a job
- A permanent position in a future-proof, internationally active company
- Flexible work schedules for the best work-life balance
- 30 vacation days for relaxation
- 10 paid sick days for children to support your family
- Modern workplace (e.g., height-adjustable desks) surrounded by greenery
- Company parking and e-charging options
- 3 goodwill days/K.O. days
- Access to a diverse selection of attractive benefits via our ROTOP Benefit 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
- Technical and managerial leadership of the Regulatory Affairs department
- Development and implementation of regulatory strategies for national and international markets
- Overall responsibility for regulatory dossiers, including submission, maintenance, and renewal
- Management of regulatory processes and communication with national and international authorities
- Monitoring of regulatory requirements and evaluation of new legal developments in the field of pharmaceutical regulation
- Leadership, development, and advancement of the Regulatory Affairs team, as well as close collaboration with Quality Assurance, Production, Medical Affairs, Pharmaceutical Development, and Business Development
Your profile
- A successfully completed degree in Pharmacy, Chemistry, Biology, Human Medicine, or a comparable natural science program
- Several years of professional experience in Regulatory Affairs within the pharmaceutical industry
- In-depth knowledge of national and international regulatory requirements in the field of pharmaceutical approval
- Proven experience of several years in team leadership and managing complex projects
- Strong strategic thinking and a structured, solution-oriented approach to work
- Excellent communication skills, confident demeanor when dealing with regulatory authorities and internal stakeholders, and fluent 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 Head of Regulatory Affairs – Pharmaceutical Approval (m/f/d) and seize the opportunity to advance your career in a modern and international environment.
If you’d like to contribute 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.