Senior Regulatory Affairs Specialist
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.
• Prepare, review, and approve labeling and SOPs
• Participate as an active team member and provide regulatory advice to project teams as required
• Respond to regulatory authorities questions with strict deadlines
• Maintain regulatory files in a format consistent with requirements
• Develop regulatory project plans
• Support regulatory activities relating to specific portfolio of products/projects (product owner)
• Maintain and update existing regulatory authorizations
• Represent or lead Regulatory Affairs in small project teams
• May review promotional material for compliance with local regulations
• Written and Verbal communication skills
• Negotiation skills
• Manage multiple projects and deadlines
• Ability to identify compliance risks and escalate when necessary
• MSc. degree or country equivalent in pharmacy or related scientific discipline with a minimum of 2 years regulatory or equivalent experience within a pharmaceutical company, CRO, or similar organization.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees van Wezel.
The Company
The company provides products and services related to pharmacy compounding and drug formulation. Our clients employees around the globe are connected by a strong commitment to save and sustain lives.Role Description
As a Regulatory Affairs Specialist you will find the perfect mix between quality and result-focus and find challenge in working on five therapeutic areas Oncology, Neuroscience, Cardiovascular and Metabolism, Immunology, and Infectious Disease.Responsibilities
• Compile and submit, in a timely manner, regulatory documents according to regulatory requirements• Prepare, review, and approve labeling and SOPs
• Participate as an active team member and provide regulatory advice to project teams as required
• Respond to regulatory authorities questions with strict deadlines
• Maintain regulatory files in a format consistent with requirements
• Develop regulatory project plans
• Support regulatory activities relating to specific portfolio of products/projects (product owner)
• Maintain and update existing regulatory authorizations
• Represent or lead Regulatory Affairs in small project teams
• May review promotional material for compliance with local regulations
Requirements
• Scientific knowledge• Written and Verbal communication skills
• Negotiation skills
• Manage multiple projects and deadlines
• Ability to identify compliance risks and escalate when necessary
• MSc. degree or country equivalent in pharmacy or related scientific discipline with a minimum of 2 years regulatory or equivalent experience within a pharmaceutical company, CRO, or similar organization.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees van Wezel.
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