Regulatory Affairs Manager
4 dni temu
We are seeking a highly skilled and experienced Regulatory Affairs Professional to join our team at TN Poland. In this role, you will have the opportunity to leverage your expertise in CMC, exceptional communication skills, and strong writing experience to contribute to the success of our clients in the pharmaceutical industry.
This position offers a wide range of responsibilities, including exposure to novel technologies, clinical trials, and post-approval activities. As a key member of our team, you will collaborate closely with a multinational pharmaceutical company, ensuring the effective planning, review, and preparation of CMC components for investigational new drugs, new drug license applications, progress reports, amendments, supplemental applications, and maintenance of approved marketed products.
Your key responsibilities will include:
- Providing technical support for the review and preparation of investigational drug applications, marketing applications, and other reports for submission to regulatory agencies.
- Ensuring that documents meet established regulatory requirements in terms of content and structure.
- Serving as a liaison between various functional groups, program teams, international regulatory bodies, and business partners, proposing solutions based on your technical experience and identifying potential project timeline delays.
- Maintaining Regulatory CMC documentation.
- Managing related databases and submission schedules.
- Assisting in the development of submission plans and project timelines.
- Preparing for and interacting with regulatory agencies during drug submissions, responding to inquiries, and participating in regulatory agency inspections.
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regulatory affairs manager
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