Senior Regulatory Affairs Specialist
Location: BelgiumSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Brussels Hoofdstedelijk Gewest Belgium.
• Responsible for one, or more, active substances of the company.
• Address all registration requirements in order to obtain/maintain approvals of active substance(s) at the EU level and formulated products at the
national level.
• Provide assistance to other Team Members for any specific requirements/questions related to the assigned substance.
Country responsibility
• Is responsible for one, or more, country in the EMEA region
• Maintain existing approvals of formulated products approved in countries your responsible for through registration requirements.
• In the same order as above, extent the approved uses of formulated products in the assigned country(ies) in accordance with the internal deadlines.
• Moreover, address registration requirements in order to obtain the approval of new formulated products in the assigned country(ies); zonal approvals, national approvals, mutual recognition, etc. in accordance with the internal deadlines.
Expertise responsibility
• Good overview of all the sections of a dossier and is able to manage and supervise the preparation of sections
• Assist the other Team Members to solve all technical issues related to her/his area of expertise for both active substances and formulated products.
• Monitor the studies in her/his area of expertise
• Prepare rebuttal documents when required
• Provide advices in order to fit with the best regulatory strategy
• Previous experience (four to six years) with legislative and regulatory process is especially helpful.
• Sound knowledge of guidelines (study conduct and assessment) for at least one specific area of the dossier.
• Flexibility, assertiveness and ability to independently and efficiently work in an interdisciplinary and international team
• Fluent in English; additional language skills would be an asset
• Self-motivated
The Company
Based in Brussels our client a subsidiary of the Norwegian parent company.Role Description
The Regulatory Affairs Team has primary responsibility for approval / renewal active substances at EU level for the processing of applications to obtain, maintain and renew registrations for products in the EMEA region.Responsibilities
Substance responsibility• Responsible for one, or more, active substances of the company.
• Address all registration requirements in order to obtain/maintain approvals of active substance(s) at the EU level and formulated products at the
national level.
• Provide assistance to other Team Members for any specific requirements/questions related to the assigned substance.
Country responsibility
• Is responsible for one, or more, country in the EMEA region
• Maintain existing approvals of formulated products approved in countries your responsible for through registration requirements.
• In the same order as above, extent the approved uses of formulated products in the assigned country(ies) in accordance with the internal deadlines.
• Moreover, address registration requirements in order to obtain the approval of new formulated products in the assigned country(ies); zonal approvals, national approvals, mutual recognition, etc. in accordance with the internal deadlines.
Expertise responsibility
• Good overview of all the sections of a dossier and is able to manage and supervise the preparation of sections
• Assist the other Team Members to solve all technical issues related to her/his area of expertise for both active substances and formulated products.
• Monitor the studies in her/his area of expertise
• Prepare rebuttal documents when required
• Provide advices in order to fit with the best regulatory strategy
Requirements
Essential• Previous experience (four to six years) with legislative and regulatory process is especially helpful.
• Sound knowledge of guidelines (study conduct and assessment) for at least one specific area of the dossier.
• Flexibility, assertiveness and ability to independently and efficiently work in an interdisciplinary and international team
Other information
Highly Desirable• Fluent in English; additional language skills would be an asset
• Self-motivated
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