Regulatory affairs consultant

Amaris is an independent, international Technologies and Management Consulting Group. Created in 2007, Amaris is already established in over 50 countries and supports 500 clients worldwide throughout their projects’ lifecycle. Our expertise covers 5 areas of innovation: Business and Management, IT/IS, Telecom, Engineering and High Technologies, Biotech and Pharma. With 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 2017, Amaris aim to reach a turnover of 180 million euros, 3500 employees and the ability to recruit one new employee every 5 hours. We expect to triple our workforce within the next years and reach an international leader position in independent consulting. Your role 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).

Profile

• 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 English (written, spoken)! Amaris is an independent, international Technologies and Management Consulting Group. Created in 2007, Amaris is already established in over 50 countries and supports 500 clients worldwide throughout their projects’ lifecycle. Our expertise covers 5 areas of innovation: Business and Management, IT/IS, Telecom, Engineering and High Technologies, Biotech and Pharma. With 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 2017, Amaris aim to reach a turnover of 180 million euros, 3500 employees and the ability to recruit one new employee every 5 hours. We expect to triple our workforce within the next years and reach an international leader position in independent consulting.