Quality & Regulatory Specialist at SofMedica ensuring compliance with quality standards and managing quality management systems. Overseeing supplier qualifications and participating in audits.
About the role
- Global Regulatory Lead managing regulatory strategies and compliance for new pharmaceutical products. Collaborating with global teams and authorities throughout the product lifecycle.
Responsibilities
- Develop regulatory strategies and submission plans for new registrations and lifecycle management, and represent regulatory requirements globally
- Prepare high-quality documentation and carry out required regulatory submission procedures in compliance with applicable regulations and internal requirements
- Ensure necessary regulatory activities to prepare and submit applications for new registrations in accordance with national regulatory requirements (e.g., local studies)
- Lead the preparation and maintenance of the Company Core Data Sheet (CCDS) for assigned products and ensure compliance with required processes
- Ensure and manage responses to regulatory authority queries
- Implement necessary regulatory activities in lifecycle management (e.g., line extensions, annual reports, post-approval commitments, change management, renewals, import licenses, company registrations)
- Lead and coordinate regulatory projects and communicate with the relevant Merz representatives, partners, or consultants as the primary regulatory member of the assigned Global Product Team (GPT)
- Prepare for and/or participate in scientific consultations with regulatory authorities worldwide, working closely with the respective Country RAMs and other regulatory functions as required
- Support the preparation of benefit dossiers or health-economic assessments, pricing and reimbursement submissions, and due-diligence processes, as applicable
Requirements
- Degree in Pharmacy, Biology, Chemistry or a related scientific discipline; a PhD is advantageous
- Minimum of 5 years' professional experience handling Regulatory Affairs aspects within the pharmaceutical industry
- Excellent knowledge of regulatory laws and guidelines, including GMP and compliance aspects as well as CMC documentation
- Strong communication skills, including intercultural competence, and excellent English (at least business fluent)
- Strong problem-solving skills and analytical thinking
- Team player with a performance-oriented mindset and persistence
Benefits
- Individual career development in a meaningful role: you help improve the quality of life for our patients!
- Hybrid working model that enables a good work–life balance
- Attractive location with good transport connections, modern workspaces and a company cafeteria
- Global family-owned company with flat hierarchies and an open, respectful corporate culture
- Attractive compensation with comprehensive social benefits
- A variety of employer-supported benefits such as WellPass, Deutschland-Ticket, Corporate Benefits and JobBike
- Further information about our benefits here
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