Regulatory Affairs Manager
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.
Keeping abreast of international legislation, guidelines and customer practices;
Keeping up to date with a company's product range;
Developing and writing clear arguments and explanations for new product licenses and license renewals;
Preparing submissions of license variations and renewals;
Setting timelines for license variations and renewal approvals;
Writing clear, accessible product labels and patient information leaflets;
Planning and developing product trials;
Interpreting trial data;
Advising scientists and manufacturers on regulatory requirements;
Preparing and co-ordinating documentation;
Project managing teams of colleagues involved with the development of new products;
Experience within a clinical trial programme environment;
Proven ability of interpreting legislation and impact to meet commercial needs;
Proven capability of successful working relationships with regulatory bodies;
Excellent communication and interpersonal skills, ability to influence;
Proven success at managing and driving a team to meet strategic goals and KPIs;
Creative and innovative, embraces the new;
Excellent attention to detail;
More than excellent command of English.
The Company
Our client is a professional Pharmaceutical organization, based in Brussel Belgium. The company helps preventing some of the most life threatening infectious diseases in the world. Pathogens against which they are developing are o.e. Ebola, polio, and influenza.Role Description
A team of quite junior RA professionals is in need of guidance. The team is missing an individual whom can take the lead and guide Regulatory processes in the department. You will be making a major contribution towards the preparation of any critical regulatory documentation of specified regulatory submissions, whilst guiding your team of four.Responsibilities
Ensure that the company's products comply with the regulations of government agencies;Keeping abreast of international legislation, guidelines and customer practices;
Keeping up to date with a company's product range;
Developing and writing clear arguments and explanations for new product licenses and license renewals;
Preparing submissions of license variations and renewals;
Setting timelines for license variations and renewal approvals;
Writing clear, accessible product labels and patient information leaflets;
Planning and developing product trials;
Interpreting trial data;
Advising scientists and manufacturers on regulatory requirements;
Preparing and co-ordinating documentation;
Project managing teams of colleagues involved with the development of new products;
Requirements
Business development skill sets, with exposure to, or having worked in, a regulatory consultancy modelExperience within a clinical trial programme environment;
Proven ability of interpreting legislation and impact to meet commercial needs;
Proven capability of successful working relationships with regulatory bodies;
Excellent communication and interpersonal skills, ability to influence;
Proven success at managing and driving a team to meet strategic goals and KPIs;
Creative and innovative, embraces the new;
Excellent attention to detail;
More than excellent command of English.
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