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CMC Development Expert
1 week geleden
This is an excellent opportunity to progress your career at a rapidly growing Regulatory Consultancy. You will have the opportunity to play a key role in the development and mentoring of staff whilst providing high-quality regulatory technical advice and product development strategies for clients.
You will provide strategic, technical and regulatory advice/services to clients with a special interest in CMC development of human medicinal products. This includes providing innovative drug development plans, data gap analyses and international regulatory strategies from a CMC perspective for complex products within the changing regulatory environment.
You will also 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.
You will lead multi-jurisdiction programs of work and deliver consulting services within your respective area of expertise. Additionally, you will lead meetings with internal and external stakeholders on matters related to any current and/or future projects, contracts, or new business opportunities.
You will support Scendea's Business Development in sales/marketing introductions and generate additional business from current clients. Furthermore, you will line manage, train, and mentor members of the Scendea Operational team, including providing technical leadership.
