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.
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.
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