(JOINING ASAP) We are seeking for a Regulatory Affairs Specialist who will be responsible for ensuring the delivery of regulatory activities performed in the platform/hub:
About us
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
- LCM, 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
Profile and Skills
- Master or higher graduate degree in a science related field, or equivalent experience along with experience in Project management or Coordinator skillset
- 6-8 years in Regulatory LCM activities preferably in Europe market
- Strong coordination skills and leadership
- Excellent organizational and interpersonal skills
- Multitasking
- Effective oral and written communication skills
- Good CMC/technical knowledge of dossier writing
- Process orientated with good attention to detail
- Sense of responsibility and meeting deadlines
- Pro-active attitude and able to work on own initiative as well as part of a team
- Ability to prioritise different workloads/multi-task
- Personal responsibility for ensuring a high standard of work
No Compromise Skillset - LCM, Post approval, Variations, Renewals, Sunset clause, Labelling changes, Safety Variations
