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United BioSource
,
London, Greater London
Regulatory Affairs Associate
Overview
Job Description
Brief Description: The primary responsibility is the creation of regulatory documents and development of regulatory strategy to achieve regulatory approvals and clearances worldwide across interventional and non-interventional studies. Working independently and reliably showing a high level of ownership for all assigned projects with a strong focus on detail and committed to quality deliverables to external and internal clients. Specific job duties: * Provide regulatory management oversight and reporting for regulatory aspects of assigned projects * Preparation of high quality, detailed regulatory documents using varied information sources * Responsible for the assembly (electronic or/and paper), publishing, production, dispatch, logging and archiving of regulatory authority submissions, correspondence and approvals * Provide regulatory expertise to clinical project teams (e.g., CTA applications, importation of clinical trial material, reporting of adverse events) * Responsible for highlighting potential challenges to external and internal stakeholders and advise on regulatory submissions procedures and best practices * Provide country specific regulatory expertise to global product development teams * Develop professional relationships with MoH staff and proactively monitor relevant governmental bodies to identify changes in legislation/regulations * Create high quality reports and other outputs according to the defined specifications to ensure timely reporting of team metrics to senior management * Educate and train project teams on regulatory submissions procedures * Other duties as assigned by EU Regulatory Operations Manager/designee, UBC Management or SOPs Desired Skills and Qualifications: * Bachelor's Degree in Life Science * Minimum 3 - 5 years' experience in regulatory and clinical research document management * Previous experience in CRO or Pharmaceutical company. * Good knowledge of the current ICH and EMA regulations related to product development in clinical trial procedures and regulations * Experience in timeline management for complex regulatory submissions * Client focused approach to work and ensure external and internal client expectations are managed and met * Excellent technical knowledge and understanding in the field of global regulatory operations * Excellent interpersonal, verbal and written communication skills * Excellent organizational and time management skills, with ability to handle multiple competing priorities across operating units * Excellent work commitment and client-focused attitude * General computer proficiency including Microsoft Word, Excel, Internet and experience with document tracking tools