(Senior) Regulatory Affairs Manager (m/f/d) Clinical Trial Applications

Full Time
Alfred-Wegener-Straße 2, 60438 Frankfurt am Main, Deutschland
Experienced Professional
September 21, 2023
Hybrid Remote


As (Senior) Regulatory Affairs Manager (m/f/d) you are responsible for supporting the conduct of Merz sponsored clinical trials of our R&D team to ensure adequate quality and meet regulatory and legal requirements.

  • Developing of regulatory strategies for planned Clinical Trials (Clinical Trials phases I-IV with IMP)

  • Preparing of regulatory documents for Merz sponsored Clinical Trials, overseeing submissions of CTAs to regulatory authorities and ethics committees, management and follow-up of CTAs in cross-functional cooperation and service providers

  • Supporting of service provider selection for Clinical Trials and management for regulatory aspects, participation in Clinical Trial Team meetings and specific external meetings (e.g., Investigator Meetings, meetings with regulatory authorities/ethics committees)

  • Preparation and coordination of specific chapters of the product dossier (e.g., Investigational Medicinal Product Dossier (IMPD), Investigational New Drug (IND)

  • Providing regulatory documents for the eTMF to ensure readiness for audit/inspection during the Clinical Trial and for long-term archiving

  • Conduct and review of entries in Clinical Trial Registries (e.g. EudraCT) to ensure compliance with regulatory requirements


  • University degree in life sciences or medical health or other equivalent professional qualifications

  • Comprehensive Experiences as Regulatory Affairs Manager as well as experiences in Clinical Trial processes

  • Advanced knowledge in clinical research and in the conduct of clinical trials and regarding relevant regulations (ICH GCP, EU CTR, MDR, FDA, etc.)

  • Professional verbal and written communication and great presentation skills

  • Advanced knowledge of medical or scientific terminology

  • Fluent communication skills (business) English

  • Team-oriented style of working and flexibility and ability to support various clinical trials simultaneously


  • Individual career development in a purposeful job: you improve the quality of life of our patients!
  • Hybrid work model that allows a good work-life balance
  • Attractive location with good transport links, modern workplaces and a company restaurant (€3.80/menu)
  • Global family business with flat hierarchies and an open, respectful corporate culture
  • Attractive remuneration with extensive social benefits
  • Variety of employer-subsidized benefits such as WellPass (€17.90/month), Germany ticket (10€/month), Corporate Benefits and JobBike

Find out more about our benefits here.


Welcome to Merz Therapeutics, a leading pharmaceutical company that addresses the needs of people suffering from movement disorders, neurological diseases, liver diseases and other health conditions.

Our pride is based on the fact that we have been focusing on innovation and development for more than 110 years and that, since our founding in Frankfurt am Main (headquarters), we are represented with our products in more than 90 countries worldwide.

Our goal is to use our products to improve treatment outcomes for patients around the world, thereby reducing the burden of suffering for affected people and their surroundings.

Our dedication and commitment to relentless research and development is to ensure that unmet patient needs are identified and appropriate treatments are provided.

Therefore, become a part of our international and motivated Merz Therapeutics family now and help us to achieve our goal:

For more information, visit https://www.merztherapeutics.com/.

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