REGULATORY AFFAIRS CONSULTANT HF

Job description

Entreprise:
Amaris is an independent, international Technologies and Management Consulting Group. Created in 2007, Amaris is already established in over 50 countries and supports more than 750 clients worldwide throughout their project's lifecycle. Our expertise covers five areas of innovation: Business and Management, Information Technologies, Engineering and High Technologies, Telecommunications and Biotech and Pharma. With more than 65 offices across the world, the Group offers proximity support to its clients in all their locations and many opportunities of international careers for employees.
In 2018, Amaris aims to reach a turnover of 260 million euros, 5000 employees and to develop its workforces with the anticipation of a further 2000 new job openings. We expect to triple our workforce within the next few years and reach a leading international position in independent consulting.
Poste et missions:
You will join Amaris as a regulatory affairs consultant and be part of a team coordinated by your manager. Together you will design technical and management solutions for our clients in the life science industry. You will be present on the client’s plant to work on mid and long term projects. As a regulatory affairs consultant you will be working in a team of consultants who are experts in the life science industry.
Your role as a regulatory affairs consultant you will be responsible of:
Preparing and updating technical regulatory documents according to documentation standard.
Creation, review and approval of regulatory requirements and technical files.
Assessment and approvals of change requests.
Maintenance of regulatory documents in document-management systems (e.g., Documentum) and document-sharing systems (e.g., SharePoint).
An overview of the regulatory requirements and changes (definition and maintenance).
Preparation of document packages for regulatory submissions.
Release of communication material (IFU, leaflets, brochures).
Profil:
You have received an engineering degree or equivalent.
You know the legal requirements for pharmaceutical industry (cGMP)
You have proven experiences in one of those above roles
You are proactive, have good communication skills, and are able to change people mind-set in the way of efficient working.
You are proficient in Dutch and English (written, spoken)!