Senior Manager Regulatory Affairs

K-Recruiting Life Sciences; Düsseldorf; Remote; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading recruiting firm is seeking a Regulatory Lead for RWE Study Submission. This remote role requires defining regulatory strategy and ensuring compliance with ethics requirements. Ideal candidates have over 8 years in Regulatory Affairs and experience with RWE/NIS, particularly in Pharma. Fluency in English and German is essential.

Qualifikationen

• 8+ years in Regulatory Affairs, ideally in Pharma or Ophthalmology.
• Experience with RWE / NIS and post-approval submissions.
• Strong knowledge of EMA / BfArM guidelines.

Aufgaben

• Define regulatory strategy and review study protocol.
• Ensure compliance with RWE / NIS and local ethics requirements.
• Oversee study conduct and documentation.
• Prepare and review CTD sections for submission.
• Manage BfArM interactions and responses.
• Maintain regulatory files and track timelines.

Kenntnisse

Regulatory Affairs

Experience with RWE/NIS

Knowledge of EMA/BfArM guidelines

Fluent in English

Fluent in German

Jobbeschreibung

Regulatory Lead - RWE Study Submission (M / F / D)

Tasks

• Define regulatory strategy and review study protocol
• Ensure compliance with RWE / NIS and local ethics requirements
• Oversee study conduct and documentation
• Prepare and review CTD sections for submission
• Manage BfArM interactions and responses
• Maintain regulatory files and track timelines

Qualification

• 8+ years Regulatory Affairs (Pharma, ideally Ophthalmology)
• Experience with RWE / NIS and post-approval submissions
• Strong knowledge of EMA / BfArM guidelines
• Fluent in English and German

Requirements : Start : asap

Duration : 6 months

Capacity : 1-4 days per week, depending on project phase

Location : Remote