Senior Regulatory Affairs Specialist
7 dagen geleden
Scendea is an international product development and regulatory consulting group delivering market-leading scientific expertise & regulatory solutions, to advance healthcare innovation worldwide. Our goal is to streamline the product development process, reduce time-to-market, and minimise overall development costs.
We are seeking a highly motivated individual to join our global team as a full-time Principal Consultant (CMC). This is a hybrid position, affiliated to our Breda, Netherlands office, with a requirement to work in the office a minimum of one day per month.
Key Responsibilities
- Provide strategic, technical and regulatory advice/services to clients with a special interest in CMC development of human medicinal products.
- Establish and maintain a high level of technical knowledge in product development and international regulatory affairs.
- Provide innovative drug development plans, data gap analyses and international regulatory strategies from a CMC perspective for complex products within the changing regulatory environment.
- Contribute to technical authorship and review of development regulatory documents including Regulatory Strategy Plans, Drug Development Plans, Clinical Trial Applications, Pre-INDs, INDs, Scientific Advice and Meeting Briefing Documents, Paediatric plans/applications, Investigator Brochures, IMPDs, Marketing Authorisation Applications, New Drug Applications, Biologic License Applications, DMFs according to area of expertise.
- Lead multi-jurisdiction programs of work and deliver consulting services within your respective area of expertise.
- Represent clients in regulatory agency interactions and provide regulatory solutions to agency objections.
- Ensure delivery of project goals within agreed timelines, maintaining oversight of project budgets.
- Lead meetings with internal and external stakeholders on matters related to any current and/or future projects, contracts, or new business opportunities.
- Support Scendea's Business Development in sales/marketing introductions and generate additional business from current clients.
- Line manage, train, and mentor members of the Scendea Operational team, including providing technical leadership.
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