Management, preparation, assembly, submission and full oversight for:
*Clinical Trial Authorisation Applications (CTAA) and amendments
*All other regulatory and patient facing documents required to support ongoing approval of clinical trials, including all required translations, in accordance with the required current legislation and guidelines
*Tracks, reports, files and maintains oversight of CTAA and amendment submission / approval progress in electronic trial master files (eTMF), clinical trials management system (CTMS) or other applicable systems
*Ensures all CTAAs and amendments are submitted in accordance with clients' timelines
*Participates in the quality control (QC) steps and ensures each submission has been checked by an appropriately qualified member of the Company regulatory group prior to submission Ensures all queries raised by Ethics Committees (ECs) and regulatory authorities (RAs) are addressed within required timeframes, including management of applicable negotiations
*Maintains metrics on a monthly basis of all regulatory submissions made by the company Supports clients in preparing for advice meetings with national RAs or the European Medicines Agency
*Maintains an awareness of the literature on cancer therapy, clinical trial design and conduct, Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials produced by RAs and ECs
*Provides training on the requirements for RA and EC submissions, and any other regulatory related issues, as required
*Keeping abreast of developments in national regulations and advises clients and the company team accordingly
*Contributes to the development of study specific Risk Management Plans Participates in bid defences meetings in order to win new business
PREFERRED BACKGROUND:
Science graduate with at least 4 years of industry experience in a regulated environment with CT RA and EC submissions in 2 or more countries
REQUIRED COMPETENCIES
Expert knowledge of ICH-GCP and local regulatory agency and ethics committee regulations and requirements
The ability to stay informed about new guidelines and regulations as they are issued by regulatory authorities
Excellent interpersonal skills Strong communication skills: verbal/written
Fluency in written and spoken English Proven ability to demonstrate problem solving skills
Proven ability to meet deadlines
Highly organised and result-oriented Good knowledge of Windows-based software programs
Ability to lead Matrix teams
