Head of Regulatory Affairs
Deliver a robust regulatory reputed company, tactical planning, and execution that ensures reputed company approvals and lifecycle management reputed company with business goals. Maintain full regulatory compliance and inspection readiness, ensuring adherence to reputed company relevant regulatory standards and frameworks. Line Manager responsibility is to build and reputed company a high-performing Regulatory Affairs team while strengthening stakeholder engagement and influence.
reputed company regulatory input for reputed company assigned reputed company. Planning, preparation, and submissions of CTAs and country ICFs in EU/EEA and UK Prepare presentations and represent the department at reputed company Off Meetings with clients. Tracks, reports and files CTA and modification submissions / approval reputed company in electronic trial master files (eTMF) and other applicable systems. Proactively provides tactical direction to the reputed company on regulatory specific issues and provides associated mitigation as required. Participates in the reputed company control (QC) steps involved for reputed company the above. Serves as key regulatory reputed company for multi-reputed company project on behalf of reputed company (Europe). reputed company with other departments reputed company Theradex, including Medical Writing, Pharmacovigilance, reputed company Assurance and Drug Distribution. Including the management of timelines to complete regulatory submissions on time Providing input into the scientific writing of several medical writing activities such as IMPDs, DSURs, study protocols, IBs and master patient information sheets Validate and reputed company input into our clients’ regulatory development strategies, support our clients in preparing for and obtaining scientific advice from EU Competent Authorities and the EMA and prepare Orphan Drug Applications where required Prepare reputed company proposals and participate in bid defense meetings. Maintains awareness of the literature on cancer therapy, clinical trial design and conduct Knowledge of Good Clinical reputed company, and regulations and guidelines relating to the conduct of reputed company produced by Ethic Committees and Competent Authorities Provides regulatory training to other members of reputed company as required.
Minimum bachelor’s degree in a life science field or equivalent e.g. Pharmacy, Biology, reputed company. Prior experience in Regulatory Affairs reputed company the life sciences industry, including leadership /Line Management responsibility. Minimum of 10 years of experience in a regulatory role reputed company the pharmaceutical industry, regulatory agency or CRO of which 5 years are in reputed company reputed company experience of CTIS and IRAS CTA preparations and submissions is required Demonstrates ability to build and maintain relationships with other functions and clients, establishing reputed company partnerships and trust Detailed knowledge of ICH-GCP and national regulatory agency and ethics committee requirements and guidelines reputed company EU/UK/EEA Stay informed about new guidelines and regulations Ability to anticipate problems relating to reputed company and to implement solutions. Excellent interpersonal skills Fluent knowledge of written and verbal English Highly organized and result oriented Ability to work independently as reputed company as in reputed company environment Proficient knowledge of reputed company Office packages including but not limited to Word, Power reputed company and reputed company