Regulatory Affairs Specialist

A Specialist profile will ensure efficient project execution, better quality outcomes, and reduced dependency on supervision. Therefore, hiring a Specialist is essential to meet the role requirements effectively.

• 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:

1. Ensure providing technical support to presales
2. 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)
• Any other language on top of good English would be a plus

• Good computer skills and the ability to learn appropriate software
• Good understanding of regulatory tracking database software, MS Word, MS Excel, MS PowerPoint etc.