Senior GRC Consultant consulting clients on GRC software RiMaGo and implementing risk strategies. Collaborating with development team and conducting training sessions in GRC.
About the role
- Global Regulatory Lead overseeing regulatory strategies and submissions for new pharmaceutical assets at Merz Therapeutics. Requires extensive experience in regulatory affairs within the pharmaceutical industry.
Responsibilities
- Develop regulatory strategies and submission plans related to new registrations and lifecycle management
- Prepare high-quality documentation and execute necessary registration procedures while ensuring compliance
- Ensure and carry out the required regulatory activities to prepare and submit applications for new registrations
- Lead the development and maintenance of the Company Core Data Sheet (CCDS)
- Respond to regulatory authority inquiries
- Lead and coordinate regulatory projects and communicate with the relevant Merz representatives, partners, or consultants
Requirements
- University degree in Pharmacy, Biology, Chemistry, or a related discipline; a PhD is an advantage
- At least 5 years of professional experience handling regulatory affairs in the pharmaceutical sector
- Strong knowledge of regulatory laws and regulations, including GMP and compliance aspects, as well as CMC documentation
- Excellent communication skills, including intercultural communication and very good English (at least business fluent)
- Strong problem-solving skills and analytical thinking
- Team player with a performance-driven mindset and perseverance
Benefits
- Individual career development in a meaningful role: you improve the quality of life for our patients!
- Hybrid working model enabling a good work–life balance
- Attractive location with good transport links, modern workplaces, and an on-site company canteen
- Global family-owned company with flat hierarchies and an open, respectful corporate culture
- Competitive compensation with comprehensive social benefits
- Variety of employer-supported benefits such as WellPass, Deutschland-Ticket, Corporate Benefits, and JobRad (JobBike)
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