• Under supervision, provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies
• Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle
• Prepare CMC responses to health authority questions during development, registration and product lifecycle.
• Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
• Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible
• Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends
• Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned
• Establish and maintain sound working relationships with partners and customers
• Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions)
• Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
• Fluent English required (oral and written), Good skills in site (local) language desired
• Regulatory experience preferred, and/or experience in drug/biopharmaceuticals
• Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from
• A broad range of scientific disciplines
• Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable
• Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload
• Effective planning, organizational and interpersonal skills.
• Reasonable approach to risk assessment.
• You will work in an international environment
Projektdauer: 9 MM++
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