CI
Cookie InformationSenior Regulatory Scientist – Regulatory Dossier Management
Regulatory Senior Scientist coordinating global regulatory strategies at Lundbeck. Managing drug development through the life cycle at a leading brain health company.
About the role
- Directs new and innovative approaches to identify, analyze, and assess regulatory and contractual compliance of aerospace systems, products and services.
- Oversees and leads collaboration with internal and external stakeholders to define, validate, and integrate highly complex airworthiness and regulatory compliance requirements; advises on incorporating into designs, operations, and procedures.
- Advises on providing a compliance statement for the airworthiness of aerospace systems and products.
- Consults on highly complex process or reported in-service fleet issue improvements for achieving regulatory compliance.
- Oversees engagement with regulators on highly complex programs or initiatives to shape and influence certification strategies, approaches, activities.
- Oversees partnership with regulatory authorities to complete validation of airworthiness to applicable requirements as authorized.
- Provides consultation on technical support, training, tools and resources provided to the delegated approval organization.
- Provides consultation on global regulatory advocacy strategies, trainings, tools, and methods.
- Provides highly advanced technical consultation across the industry on aerospace regulatory compliance projects and programs.
- Informs top leadership of new and innovative research and advancements related to regulatory compliance engineering.
- Serves as a spokesperson on regulatory compliance engineering technical capabilities and future direction.
- Leads participation in industry standards development and benchmarking to inform new and innovative solutions.
Requirements
- Bachelor of Science degree from an accredited course of study in engineering, engineering technology (includes manufacturing engineering technology), chemistry, physics, mathematics, data science, or computer science
- 20+ years of related work experience or an equivalent combination of education and experience
- 5+ years of experience in a role developing, leading, and executing projects and utilizing project processes / skills
Benefits
- health insurance
- flexible spending accounts
- health savings accounts
- retirement savings plans
- life and disability insurance programs
- paid time off
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CI
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