Regulatory Affairs Manager

Regulatory Affairs Manager

Germany - Munich

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

For our growing team in Munich, we are looking for a dedicated and experienced Regulatory Affaris Manager to cover regulatory submissions of clinical trials as well as marketing authorisations for registered products.

Responsibilities

• To coordinate and manage the submission of clinical studies to the EU regulatory/health authorities (RA) and ethics committees according to the Client requirements, SOPs, EU and local legislation and regulatory requirements
• Executes and prepares submission to RA (and EC if applicable) concerning clinical studies
• Ensures that the documentation submitted meets local regulatory requirements
• Communicates with local and international regulatory authorities
• Reviews and adapts local documentation for RA/EC submission
• Coordinates or manages preparation of study documentation relating to clinical study regulatory timelines, specific trial drug/ investigational device regulatory requirements and labeling in collaboration with the project manager and CRA
• Enters or provides to be entered into tracking systems the RA submission and approval data and provides predictions of expected approval dates
• Submits updated documentation to RA
• Notifies RA about trial initiation, investigator change, site change or site/study closure and other as applicable
• Provides support to local audits and inspections
• Regularly searches for new regulatory information and suggests process changes

Experience

• Degree in a scientific discipline or relevant other experience
• At least 2 years of regulatory affairs experience in clinical research
• Knowledge of current local and international legislation and regulatory requirements
• Basic understanding of drug development
• Knowledge of key aspects of the local regulatory process
• Document management and archiving practices
• Working in a regulated environment
• Experience managing a team is an advantage
• Fluency in German and English

We offer

• Friendly and professional environment
• Flexible working hours
• Possibility to work partially from home office

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