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Regulatory Affairs Director
- Contract
- Senior/Director & VP
- Netherlands
This vacancy has now expired. Please see similar roles below...
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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