Regulatory Affairs Director
1 maand geleden
Proclinical are recruiting for a Regulatory Affairs Director to join a biotech organisation. This role is on a contract basis and is located in Leiden.
Please ensure that you are eligible for working in the location without any sponsorship or relocation assistance.
Responsibilities:
Supervise the regulatory landscape to keep ahead of new developments and efficiently discuss them across the business.Monitor all aspects of regulatory affairs in both a small and dynamic publicly listed business.Guide the preparation of high-quality regulatory applications such as INDs/CTAs and handle the clinical trial approval procedures.Offer training on regulatory expectations to project team members.You will guarantee that the content, quality and format of regulatory proposals comply with suitable guidelines and regulations.Partake in the execution of systems & procedures to develop international business value.Discuss both with internal and external partners, which involves EMA, FDA and any other regulatory authorities.Other duties may be assigned.Key Skills and Requirements:
Educated to an advanced degree level in a life science or applied science field.Demonstrable experience in regulatory affairs within a pharmaceutical/biotechnology organisation with expertise on various phases of drug development.Familiarity working with large pharmaceutical organisations with a mix of exposure to smaller organisations with comprehension of the challenges facing a novel company going through rapid enhancement.Familiarity with chairing meetings with regulatory authorities and successful CTA/IND proposals.Acquaintance with liver/cardiovascular diseases, rare disease drug development, evolving technologies and/or platforms and the new EU Clinical Trials Regulation would be beneficial.Communication skills both verbally and in writing.Able to think tactically and creatively with the capacity to make decisions as well as resolve issues.A flexible individual with integrity and a clear sense of responsibility.A result focused individual with a high level of tenacity, enthusiasm and energy.Capable of working cross-functionally/matrix leadership.Works well in a team as well as independently.A patient focused mindset.Able to work within a fast-paced environment.Capable of prioritising various tasks simultaneously.If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
#Regulatory
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