Description
Harvey Nash is currently looking for a regulatory affairs consultant for one of its customer.
Position Overview- Basic Functions & Responsibility: Essential function(s) includes, but is not limited to:
Under the direction of Director Regulatory Liaison - Europe, incumbent is responsible for providing strategy and assistance for assigned variations related to merger activities and initiatives to ensure registration data are both completely and properly presented so as to obtain timely approvals for the filed variations to ensure licenses for our client products are retained and up-to-date in Europe. Troubleshoots and resolves any problem on the critical path for product maintenance. Coordinates European subsidiary regulatory managers in the execution of MSDRL regulatory strategies activities and thereby ensure timely approval
Primary activities include, but are not limited to:
1. With guidance from the Director Regulatory Liaison - Europe, the incumbent coordinates and executes regulatory filings resulting from legal entity integration related changes for the products registered via one of the European registration procedures. Incumbent will cover scientific/strategic input and content review of such required regulatory filings.
2. Incumbent will coordinate with RA-I Liaison personnel the timely completion of appropriate supporting documents to ensure consistency with European Union (EU) requirements.
3. Maintains a sound scientific & regulatory knowledge and expertise within the field of CMC variations and in particular the new variation regulation requirements and current practices.
4. Negotiates with RA-I liaison personnel preparing reports/documents to ensure that these client scientists fully understand European regulatory requirements.
5. Assists subsidiary personnel by providing scientific and strategic support, when necessary, permitting them to be more effective in negotiations with their respective agencies. Also ensures that information provided to local agencies accurately reflects MRL management position. Where appropriate assists in the planning and conduct of meeting with the European Registration Managers.
Skills
At least 8 years of experience with regulatory affairs. The experience in regulatory must include experience with preparing and filing variations (both administrative, CMC and clinical variations) within the European procedures- MRP/DCP and CP. Proven record of successful filings of variations according to the new variation legislation. Incumbent must have excellent communication skills (both oral and written), a working knowledge of personal computers, and be able to work effectively within a team environment. General competency, flexibility and negotiating skills are required. Fluent in English isa must. The incumbent must be available to work out from the Brussels office.