Senior Regulatory Affairs Officer

Proclinical is seeking a Senior Regulatory Affairs Officer to be based in Amsterdam on a permanent basis. As senior Regulatory Affairs Officer you are responsible for compiling and following up all matters relating to the registration dossiers of company medicines. You play a pro-active role in guiding various projects from the RA department.

Job Responsibilities:

• Compiling, maintaining and reviewing registration dossiers
• Advising and supporting other departments in the field of national and international legislation and regulations
• Interpreting and implementing (inter) national laws and regulations for the realization of registration dossiers
• Checking registration dossiers against (inter) national legal requirements and ensuring corresponding changes
• Ensuring the creation and monitoring of product information (including SmPC, package leaflet and mock-ups)
• Functioning as an RA lead in managing the registration files. This includes scheduling submissions, assessing changes to registration impact, escalating relevant problems to the RA manager and performing quality control of documents for submission
• Guiding, training and advising Jr. RA employees in daily work
• Functioning as a direct contact with governments and other external parties
• Providing strategic input with regard to maintaining the product specification and during the development process of company products.

Skills and Requirements:

• University degree in pharmacy, biochemistry, medical biology, medicine or similar study;
• At least 5 years of relevant work experience in the pharmaceutical industry of which at least 3 years within regulatory affairs;
• Experience with the independent execution of multidisciplinary projects within an organization;
• Excellent control in word and writing of both the Dutch and English language;
• Accurate, able to plan and organize well, cooperative and advisory and coaching skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Gilles Maricaux on +3224460153 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.