Regulatory Affairs Manager handling the drug approval process and compliance documentation for a leading global pharma company based in Munich with hybrid work.
Responsibilities
Independent responsibility for managing regulatory procedures for medicinal product approvals
Preparation of regulatory submission documentation in eCTD format and submission to regulatory authorities
Life-cycle management (renewals, variations)
Direct contact with regulatory authorities and serving as the point of contact for internal and external Regulatory Affairs queries
Maintenance and optimization of the regulatory information database
Drafting and reviewing product information texts
Requirements
Completed degree (e.g., pharmaceutical or natural sciences)
Professional experience in Regulatory Affairs
Excellent German and English language skills
Analytical thinking, quick comprehension, and strong organizational skills
Team player with strong communication skills
Benefits
Flexible working arrangements (including remote work)
30 days of vacation + 3 bridge days
A supportive team
Attractive salary and comprehensive social benefits (including retirement and healthcare benefits)
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