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Regulatory Biological CMC Specialist (ATMP) Netherlands - Oferta z Jobs.pl

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Regulatory Biological CMC Specialist (ATMP) Netherlands

Nr ref.: /JOBS.pl

  • TEC Group International have been tasked with finding our global client a talented Biological CMC Specialist for the office in the Netherlands. This profile will be responsible for all Regulatory CMC tasks related to the development projects. This candidate will quickly be moved into a management position by the end of the year if all goals are met and a full relocation package is on offer for members of the EU.

    Job profile

    The successful candidate will:

    · Be an experienced and proactive Regulatory CMC expert with Biological experience who can enable our fast to patient strategy through close liaison with our pharmaceutical development department

    · As part of the CMC project teams find the best regulatory strategy and pathways for CMC plans and know the potential shortcuts and pitfalls

    · Advice on regulatory and non-CMC consequences of CMC decisions

    · Drive Agency interactions on CMC issues

    · Be involved in inspection Q&As ensuring proper response to Agencies

    · Review all CMC regulatory documents from a regulatory strategic perspective

    · Generate regulatory risk assessments for CMC changes

    Candidate profile

    · CMC and preferably ATMP, drug-device Regulatory expert knowledge

    · A solid CMC regulatory network especially in the UK.

    · Experience with the EU drug-device regulatory environment including UK and EU Regulatory Agency interactions

    · The wish to make a difference in our fast-paced development projects

    The department

    You will be part of the Regulatory Affairs & Pharmacovigilance department. We are a small and newly established team that emphasizes supporting and challenging each other in order to find the best regulatory strategies for the company's projects. They are high-performing, ambitious, work independently and take responsibility for our own projects while focusing on functioning and delivering as a team. They aim to make a difference for the project teams and for the development and approval of our products. We are busy but we make sure we have fun in our daily work. While we lay out the regulatory strategies internally, we collaborate with external regulatory contractors.

    We offer

    As an employee you will be part of a stimulating and informal innovative working environment where you will interact with both colleagues and partners to deliver on our ambitious corporate goals. We look at every new employee as an individual and plan out what work life balance you would like. We offer multiple ways of working from home and minimum travel to those with families.

    We offer an exciting, interdisciplinary and challenging job at a workplace, which encourages continuous learning at work and sharing of best practices. We have an inclusive corporate culture where we believe in development of our employees and work-life balance.

    A very competitive remuneration package including pension scheme, share options, premium health care, company car, insurance as well as breakfast and lunch plan, physiotherapy, fitness room and social clubs.

    The company is based in London England and is offering a relocation package if needed.


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