Regulatory Affairs Officer
Location: NetherlandsSIRE® 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 Zuid-Holland Netherlands.
- Providing regulatory content support for products by interacting with project teams, LOCs and regulatory agencies (as appropriate) and supporting submissions as appropriate.
- Providing guidance and support to product development teams on regulatory issues.
- Excellent relationship building skills with the ability to communicate at all levels
- Knowledge of how Health Authorities operates and a good general knowledge of HA organizational structure and individual responsibilities in those structures
- 5-8 years European and/or Global regulatory experience
- Proven Full product lifecycle experience
- Proven regulatory strategy experience
- Experience within a clinical trial programme environment and CTA procedures.
- Proven expertise of Pharmaceutical Regulatory Affairs on an international basis.
- Business development skill sets with exposure to or having worked in a regulatory consultancy model.
- 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.
- Excellent communicator, both verbal and written.
- More than excellent command of English.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Windimi Post.
The Company
Our client is a professional Pharmaceutical organisation, based in Netherlands. In our organization, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are of crucial importance. We are continuously looking for enthusiastic, talented people who have the ambition to develop themselves.Role Description
My client is looking for a Regulatory Affairs Senior Associate Oncology.Responsibilities
- Supporting all regulatory activities associated with the development, post-approval and life-cycle management for designated products within the Oncology portfolio- Providing regulatory content support for products by interacting with project teams, LOCs and regulatory agencies (as appropriate) and supporting submissions as appropriate.
- Providing guidance and support to product development teams on regulatory issues.
- Excellent relationship building skills with the ability to communicate at all levels
- Knowledge of how Health Authorities operates and a good general knowledge of HA organizational structure and individual responsibilities in those structures
Requirements
- Degree or equivalent in a Life Science.- 5-8 years European and/or Global regulatory experience
- Proven Full product lifecycle experience
- Proven regulatory strategy experience
- Experience within a clinical trial programme environment and CTA procedures.
- Proven expertise of Pharmaceutical Regulatory Affairs on an international basis.
- Business development skill sets with exposure to or having worked in a regulatory consultancy model.
- 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.
- Excellent communicator, both verbal and written.
- More than excellent command of English.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Windimi Post.
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