Regulatory Affairs Specialist

• Contribute to regulatory activities performed on the RA Platform/the Hub
• Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions, interaction with health authorities on behalf of PLG customers
• To contribute to the production of client administrative documents and reports to be included in regulatory submissions
• Support for Initial MA application, all kind of LCM activities
• Act as (Single) Point of Contact and oversee clients’ portfolios
• Cross-functional co-ordination
• Communication with external vendors
• Communication/Co-ordination with client and participate in client’s meeting, preparing MoM etc
• Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements
• Systems Management and Administration
• Document and track regulatory submissions and regulatory authority approval
• Gain regulatory authority approval
• Provide regulatory support to clients and associate companies
• Assess regulation and inform the clients about the impact on their products or activities
• Liaise with sponsor head-office and affiliate departments on regulatory issues
• Liaise with external regulatory authorities as required
• Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling
• Review tasks for, support and mentor Regulatory Affairs Associates
• Provide on-going regulatory support to the Regulatory Affairs Team
• Lead and to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives
• Contribute to data entry in PLG tools enabling measurements of KPI and metrics for regulatory services supplied by the platform/hub
• Control that invoicing is correctly set
• Assist the RA Platform or Hub Leader or Coordinator in presales
• Ensure providing technical support to presales
• Ensure adequate technical description of the proposals and support sales for quotation evaluation
• Ensure that invoicing is done correctly
• Contribute to the input of data into PLG tools enabling KPI/metrics for regulatory services provided by the platform/Hub

• Bachelor’s or higher degree in a science related field, or equivalent experience
• 7-8 years of EU RA technical and project management experience
• Good English language and grammar skills (written fluency a must, verbal fluency preferred)
• Good computer skills and the ability to learn appropriate software
• Good understanding of regulatory tracking database software, MS Word, MS Excel, MS PowerPoint etc.
• Excellent organizational and interpersonal skills
• Ability to work well within a team

Any other language on top of good English would be a plus