From medical writing to project management: We are the perfect full service CRO for your clinical trial.

Regulatory Affairs Manager (m/w)

At Proinnovera we revolutionize and transform Clinical Research by radically thriving for innovative processes. As a contract research organization of clinical research we have successfully performed clinical trials from phase I to IV since 1997 to assess the efficacy and safety of new pharmaceutical products for human use. By using and developing own digital technologies in combination with our unique and long-standing experience, we create a smooth and high-quality process of study execution.

Based on our continuous growth in the past years, we are expanding our international reach and increase our study activities in the field of Dermatology and Immunology.

If you want to make impact with your work by developing innovative ideas and transforming Clinical Research with us, we are looking forward to having you as a part of our team.

(earliest possible date)

Regulatory Affairs Manager (m/w)

You are responsible for the project-specific interaction with competent authorities (CA) and local authorities (LA) as well as ethics committees (ECs). In addition to that you are involved in proposal processes and the planning of national and international clinical trials with regard to regulatory affairs.

Your main functions:

  • Contribute to definition of project scope, goals and deliverables regarding regulatory aspects in collaboration with sponsor, senior management and other relevant stakeholders
  • Determine needs around regulatory aspects from national as well as international CAs, LAs and ECs and oversee realization of needs
  • Compilation of documents for submission to the CAs and ECs
  • Submit the Clinical Trial Application to the CAs and the ECs and coordinate corresponding processes of external contractual partners
  • Notification of the LAs
  • Responsible for all project-specific correspondence with ECs, CAs, LAs in close consultation with the responsible PM and if necessary with the sponsor
  • International cooperation with contractual partners with regard to regulatory processes
  • In case of audits, support the PM and if necessary the auditor in all regulatory study aspects

Your qualification profile:

  • Education: University degree, preferably in a scientific or medical discipline; PhD preferable but not mandatory
  • Expertise: Knowledge of the relevant regulatory framework conditions (national and international), Knowledge of general processes of clinical trials, relevant further training preferable
  • Experience: Experience in the submission and notification processes of clinical trials (preferably international / EU-wide), Experience in the general processes of clinical trials
  • Personal Qualification: highly structured way of working, ability to work independently, esp. to prioritize according to deadlines, strong communication skills, cooperative and goal-oriented way of working in an international environment, willingness to learn, flexibility and openness to various task areas.
  • Skills: Strong and precise oral and written communication skills in German and English; very good PC skills (MS Office software: Word, PowerPoint, Outlook and Excel)

Why working with us:

  • Quality & Experience: More than 20 years of consolidated knowledge in planning and execution of clinical trials based on a stable and wide network in clinical research
  • Unique culture: We are a dynamic and diverse team. Transparency, cohesion and mutual appreciation characterize us. A culture which stands for the perfect mix of secure corporate and impactful startup attitude.
  • Innovation & Inspiration: Doing the old even better and tackling the new with an innovative approach. We offer you the freedom for your own ideas and responsibility in the field of a globally active company
  • Digital Mindset: Through the internal use of digital technologies, we accelerate our processes continuously and revolutionize the pharmaceutical industry with a digital mindset.
  • Benefits: attractive salary, complete equipment (company cell phone, laptop)

 

Are you interested?

In this case we are looking forward to your convincing application to the human resources department via email stating your salary requirement as well as your earliest possible starting date.

Looking for a job in clinical research with special focus on dermatology? Contact Ms Afra Dimetros, Head of Human Resources at proinnovera today.

Afra Dimetros
Director Human Resources

If you are interested please contact us: bewerbung@proinnovera.com

proinnovera GmbH

Clinical Research Organization

Ms Afra Dimetros
Director Human Resources

Wienburgstrasse 207
48159 Muenster, Germany

Tel. + 49 251 270 778-0