Freelance Regulatory Affairs Manager (REF7134O)

Job Description

A Manager, Regulatory Affairs will create and maintain the approval documentation in eCTD format for national and international approval, extension, and modification projects. Additionally, the Manager, Regulatory Affairs willpro-actively recognise potential regulatory issues, while also identifying solutions and opportunities,review labelling for regulatory compliance, andunderstand the complex and changing regulatory environment. This is a 1 year fulltime freelance project starting in November. Presence on site will be required.

• Creation and maintenance of the approval documentation in eCTD format for national and international approval, extension, and modification projects
• Procurement of internal and external product data relevant for approval, as well asthe preparation of applications for approval or responses to deficiencies.
• Planning, coordination, and implementation of national, European, and international
• Approval, modification, and renewal procedures
• Answering regulatory questions from international approval authorities and customers or internal departments
• Evaluation of stability tests, approval documentation, and clinical studies(Bioequivalence), as well as preparation of pharmaceutical expert reports
• Support and review of regulatory compliance

Qualifications

• Postgraduate degree in a life sciences discipline
• Dru regulatory affairs and EMEA submission experience
• Good working knowledge of the pharmaceutical industry
• Confident handling of approval databases and eCTD management systems
• Excellent interpersonal skills
• Keen attention to detail
• A positive, entrepreneurial, can-do attitude
• Ability to work independently but contribute pro-actively to a project team
• Fluency in German and English

Additional Information

All candidates must be legally eligible to work in Germany.

ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.