Regulatory Affairs Team Lead

We are seeking a Regulatory Affairs Team Lead with Coordination and Team Management skillset  who will be responsible for ensuring the delivery of regulatory activities performed in the platform/hub:

Responsibilities

• To contribute to the production of client administrative documents and reports to be included in regulatory submissions
• 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 as well as external regulatory authorities when required
• Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labeling
• Review tasks for, support, and mentor Regulatory Affairs Associates/Officers
• Provide ongoing regulatory support to the Coordinator and the 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

Profile and Skills

• Master or higher graduate degree in a science-related field, or equivalent experience along with experience in Project management/ Team Management or Coordinator skillset
• Min 5-8 years of experience in a regulatory affairs department required + relevant experience in EU regulations
• Strong coordination skills and leadership
• Client communication and facing experience
• Excellent communication skills in English (written fluency a must, verbal fluency preferred)
• Excellent organizational and interpersonal skills
• Good computer skills and the ability to learn appropriate software
• Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel
• Ability to work well and lead a team
• Process orientated with good attention to detail
• Sense of responsibility and meeting deadlines
• Pro-active attitude and ability to work on own initiative as well as part of a team
• Ability to prioritize different workloads/multi-task
• Personal responsibility for ensuring a high standard of work