German
English

Manager Regulatory Affairs (m/f/d)

Eckert & Ziegler Radiopharma GmbH
Berlin Headquarters
Presence / Mobile
Work experience

Medicine, Pharmacy, Laboratory
Quality Management, Quality Assurance
Fulltime
Published: 2024-07-12

CONTRIBUTING TO SAVING LIVES | WIR HELFEN ZU HEILEN

Eckert & Ziegler Radiopharma GmbH, a subsidiary of the renowned and internationally active Eckert & Ziegler Group, has been an important and reliable partner to the radiopharmaceutical industry for over 20 years.

Radiopharmaceuticals have become an indispensable part of modern medicine. They play a particularly important role in the research and development of new therapeutic options, but also in the treatment and diagnosis of various types of cancer. We supply clinics, pharmaceutical companies and institutes with GMP-compliant radioisotopes and radiopharmaceuticals and develop tailor-made solutions for research companies. With our support, new processes and methods are created from development to production.

Join our ambitious and highly skilled team and help to heal.

Your contribution to success

Preparation and maintenance of documents for the regulatory approval of (radio)pharmaceutical products in German and English
Preparation and maintenance of product information texts
Conducting national and international registration and renewal procedures and preparing change notifications
Liaise with external experts and service providers as well as national and international regulatory authorities
Regulatory support for change control procedures and compliance with pharmacovigilance requirements
Regulatory support for the development of medicinal products
Identification of regulatory requirements and standards

This qualifies you

Degree in Pharmacy, Chemistry, Biology or comparable qualification
Knowledge of preparing and maintaining marketing authorisation dossiers in English and experience of working with product information texts
Business fluency in German and English, both written and spoken
Independent, meticulous and well-structured working style
Confident use of MS Office package, Adobe Acrobat and internet approval tools
Strong communication and comprehension skills

You can look forward to

Family-friendly organisation with flexible working hours and remote working opportunities
Permanent and secure job
Attractive remuneration, as well as savings and benefits vouchers
30 days holiday and paid time off for specific reasons, e.g. relocation, cancer screening or sick days for children
Health benefits such as health insurance, health days and company fitness with the Campus Vital Card
Interesting and challenging work with a high degree of personal responsibility in the radiopharmaceutical sector
Pleasant working atmosphere in a dedicated team
Opportunities for personal development
Flat hierarchies and short decision paths
Various internal and external catering facilities
Parking facilities and electric car charging at employee rates
In-house bicycle storage with free charging of e-bike batteries
Attractive working environment at the Berlin-Buch health centre (www.berlin-buch.com)

We look forward to receiving your application!

Please apply by using our online application form, which can be easily access by clicking on the "Apply Now" button at the end of each vacancy.

In our search for new talent, we welcome all applications regardless of gender, age, race, sexual identity, disability, religion or belief. We value diversity and the different perspectives you can bring to our business. We welcome your application even if you do not meet all of the criteria, because we value individual skills, motivation and potential over categorisation.

Show us what makes you special. Take the next step in your career and send us your informative application documents, stating your salary expectations and your earliest possible starting date.

Do you have any questions? Please contact us: