Senior Manager GRA CMC – Gene Therapy (gn)
Our client is a global biopharmaceutical company headquartered in Australia, with major R&D sites in the US, Switzerland and Germany. Currently we are looking for a Senior Manager Global Regulatory Affairs CMC – Cell & Gene Therapies, to join the team in Bern and support the filing and clinical development of several breakthrough therapies that will have a huge impact on patients.
- Global company with international team
- Cutting edge development pipeline and first to market therapies
- Very pleasant working atmosphere
- Home office
- Particularly good career development opportunities
- Very attractive salary and benefits package with good development opportunities within the team
- Responsible to establish and maintain regulatory expertise and global oversight for CMC regulatory aspects related to CGT/ATMPs.
- Responsible for development and implementation of global CMC regulatory strategies for relevant CMC projects with a view to reach approvals in the most efficient way while ensuring compliance with global regulatory requirements.
- Member of cross-function project and delivery teams and point of contact interfacing with relevant technical expert departments for project planning purposes, compilation and updates of technical documentation and for addressing CMC regulatory questions.
- Provision of high quality strategic regulatory advice and input into CMC project feasibility, complex changes and other strategic/subject assessments as required.
- Overseeing of scheduling and prioritization of all CMC regulatory submissions for the assigned products as well as maintenance of the content of relevant parts of the regulatory dossier(s), including timely provision of high-quality responses to CMC related Health Authority questions.
- Coordination, compilation and review of regulatory CMC documentation (Module 2.3, Module 3, IND/IMPD including Information Amendments/Substantial Modifications, Briefing Books for Health Authority interactions) and related documents for CMC submissions according to agreed timelines
- Interpretation of existing or new regulatory requirements, evaluation of draft guidelines.
- Overseeing and interpretation of relevant existing or new regulatory requirements, evaluation of draft/existing guidelines, writing impact assessments, leading gap analysis and proposing solutions and strategies to remediate risks.
- Provision or support of timely and compliant regulatory assessments as well as efficient execution of CMC changes.
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