Regulatory Affairs Director

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