Cyber Risk & Compliance Analyst ensuring client compliance and cybersecurity governance. Collaborates across teams to manage RFPs, contracts, and third - party risk management processes.
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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Senior Manager in Regulatory Submission Compliance overseeing CMC documentation and submissions. Ensuring high - quality regulatory compliance for clinical and commercial activities in Biotech.
Director of Trade Compliance at Blue Origin providing leadership and oversight for trade compliance in aerospace. Driving compliance strategy while ensuring alignment with business objectives and international operations.
Senior Regulatory Affairs Specialist at PROCEPT BioRobotics focusing on regulatory strategy for medical devices. Lead regulatory submissions and support compliance in innovative surgical robotics.
Senior Regulatory Affairs Specialist ensuring compliance for medical device labeling, managing regulatory project activities. Collaborating across functions to support global regulatory submissions in a medical device company.
Risk and Compliance Officer providing guidance on regulatory obligations for Sharesies. Contributing to the risk and compliance program while addressing challenges in a dynamic environment.
Senior Manager in Ethics and Compliance at PwC focusing on compliance investigations and guidance. Collaborating with diverse teams while ensuring the firm's code of ethics is upheld.
Senior Regulatory Affairs Specialist managing regulatory submissions and compliance for medical devices in the healthcare industry. Collaborating with cross - functional teams on product development and lifecycle management.
Senior compliance professional managing Credit Risk and Fair Lending oversight at PayPal. Leading risk assessment projects and collaborating across teams to ensure compliance and responsible lending practices.
Analyst responsible for fiscal compliance processes for transportation solutions in Mexico. Ensuring timely document collection and compliance with SAT requirements while collaborating with internal teams.