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.
About the role
- Regulatory Affairs Manager supporting approval and maintenance of medicinal products at Merz Therapeutics. Utilizing knowledge of global regulatory quality requirements and maintaining compliance standards.
Responsibilities
- Apply knowledge of global regulatory and quality requirements to support the approval and maintenance of medicinal products
- Create, review, and update high-quality CMC documentation to obtain and maintain product approvals, ensuring compliance with global regulatory requirements
- Support the preparation of IMPDs for clinical trial applications
- Implement change control processes, coordinate regulatory assessments, and maintain CMC submission and approval status
- Manage inquiries related to quality documentation from regulatory authorities, ensuring timely and accurate responses
- Oversee regulatory CMC projects, liaise with Merz representatives and partners, and coordinate third-party services
- Develop regulatory CMC strategies and represent regulatory requirements within project and interdisciplinary teams
- Maintain a detailed understanding of global and national CMC regulatory requirements and best practices
Requirements
- Completed scientific degree in Pharmacy, Biology, Chemistry or a related field; a doctorate is an advantage
- 3–5 years' experience in regulatory affairs or in a department responsible for CMC matters (e.g., analytics, development, or quality control)
- Analytical and systematic thinking
- Strong negotiation skills and ability to work effectively in teams
- Solution-oriented approach with a strong focus on compliance and quality
- Strong communication skills, including excellent command of English
Benefits
- Personalized career development in a purposeful role — you help improve the quality of life for our patients!
- Hybrid working model that supports a good work–life balance
- Attractive location with good transport links, modern workspaces and a company restaurant
- Global family-owned business with flat hierarchies and an open, respectful corporate culture
- Competitive remuneration with extensive social benefits
- Variety of employer-subsidized benefits such as WellPass, Deutschland-Ticket, Corporate Benefits and JobBike
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Senior Manager in Regulatory Affairs overseeing submission management and regulatory compliance. Leading cross - functional teams in a neuroscience - focused biopharmaceutical environment.
Local Compliance & Ethics Officer at Teva Germany serving local management and compliance program. Leading compliance initiatives and collaborating with various stakeholders while managing risks and providing guidance.
Manager of Asset Strategy and Regulatory Compliance driving asset management goals for Eversource. Ensuring regulatory compliance and system performance for electric transmission and substations.
IT Governance, Risk and Compliance Analyst managing compliance initiatives like NIST and ISO standards in technology and security operations.
Compliance Specialist overseeing regulatory adherence for youth programs in Gainesville. Ensuring DCF compliance and supporting youth program safety and integrity.
Technologist at FortisBC ensuring compliance with BCUC Critical Infrastructure Protection Standards. Focus on integrating business technology and providing technical support.
Compliance Examiner Business Lead at Freddie Mac conducting on - site examinations and ensuring financial activities align with laws. Engaging with financial institutions to enhance operational effectiveness.
Compliance Professional supporting Freddie Mac's investment and ethics policies. Engaging with compliance risks and overseeing regulatory obligations to promote best practices.
Compliance Officer at Hewlett Packard Enterprise ensuring adherence to compliance regulations, managing AML programs, and conducting risk assessments. Driving compliance culture across markets and delivering training to employees.