Regulatory Affairs Manager

Proclinical is seeking a Senior Regulatory Affairs Manager for a global biotech leader. This role is a 3-6-month contract and will be based in Amsterdam.

Job Responsibilties:

• Lead regulatory strategy and operational implementation of development programs
• Prepare and compile the Common Technical Document (CTD) for dossier submission according to regulatory requirements of different regions (e.g. EU, USA, Canada, Japan)
• Coordinate the dossier submission process
• Identify the required documentation for submissions based on a deep knowledge of the respective regulatory environment and negotiate the delivery of documents in accordance with the program timelines
• Review and write high-quality Regulatory Affairs documentation during development and product registration based on agreed regulatory strategies
• Assure technical congruence and regulatory compliance
• Meet agreed timelines and publishing requirements
• Build and maintain a sustained liaison with Regulatory Authorities
• Lead preparation and conduct of Regulatory Authority meetings in close collaboration with the program team
• Regulatory input and support of development programs
• Information on regulatory requirements of various authorities
• Regulatory input to the preparation of development documents (e.g. input to development plans, IMPDs, briefing books, clinical study protocols)
• Develop regulatory strategies for the submission of new programs as well as provide input on general development concepts
• Prepare responses to health authority questions during development and registration
• Monitor and lead the regulatory life cycle management process for the development programs
• Keep knowledge up to date with regard to guidelines and regulatory trends
• Ensure working compliance with the respective SOPs
• Responsibility for adherence of expenses to budget (regulatory affairs and project related)

Skills and Requirements:

• Ph.D. in natural sciences or equivalent education
• 5 or more years of Regulatory Affairs experience in drug development in the biotechnology or pharmaceutical industry environment
• Excellent understanding of regulatory requirements and guidelines for filings worldwide and critical evaluation of emerging requirements and guidelines for new drugs.
• Excellent communication and presentation skills
• Fluent in oral and written English
• Excellent team player

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 Badria Kahie on +44 203 8718 094 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.