508 Compliance Specialist working with the Office of the Inspector General for the DoD. Responsible for ensuring electronic accessibility for compliance with Section 508 regulations.
MT
Hybrid Regulatory Affairs Manager – Labeling and Regulatory Intelligence
Posted 2 months ago
About the role
- Regulatory Affairs Manager overseeing compliance and life cycle management of medicinal products. Working in a global leader in specialty neurology with a strong commitment to innovation and growth.
Responsibilities
- Support regional regulatory strategies, approvals and life-cycle management of medicinal products, ensuring compliance with regulatory and legal requirements
- Review Company Core Data Sheets (CCDS)
- Implement CCDS into national product information texts (EEA/CH/UK), coordinate translations, and ensure compliance and timely delivery
- Initiate, review and approve artwork changes (EEA/CH/UK) in close cooperation with local Regulatory Affairs teams
- Support submissions and responses to regulatory authority queries
- Optimize labeling and artwork processes; train colleagues and act as a key user for Merz’s artwork management system
- Lead, monitor and further develop the Regulatory Intelligence process within global Regulatory Affairs
Requirements
- University degree in a scientific discipline or Pharmacy; pharmacist license/qualification advantageous
- Minimum 2 years’ professional experience in the pharmaceutical industry and Regulatory Affairs; experience in labeling is a plus
- Strong knowledge of international regulatory frameworks and standards
- Strong project management skills and analytical thinking
- Team player with excellent communication and problem-solving skills
- Fluent German and English (business fluent)
Benefits
- Individual career development in a purpose-driven role — contribute to improving patients’ quality of life
- Hybrid work model enabling a good work–life balance
- Attractive location with good transport links, modern workspaces and a company canteen
- Global family-owned company with flat hierarchies and an open, respectful corporate culture
- Competitive compensation with comprehensive social benefits
- Variety of employer-sponsored benefits such as WellPass, Germany ticket (Deutschland-Ticket), Corporate Benefits and JobBike
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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