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

YOUR CONTRIBUTION

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

YOUR PROFILE

• 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

YOUR BENEFITS

ABOUT US