Regulatory Manager/ Senior Regulatory Manager (Clinical Trials)

Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline. 5 years Regulatory experience (Manager level) or 7 years Regulatory experience (Senior Manager level). Computer literacy (MS Office/ Office 365). Fluent in English. Regulatory affairs experience working for a Clinical Research Organisation. Experience leading Clinical Submissions. Informed knowledge of the drug development process, regulatory milestones, and specialized knowledge of regulatory activities for at least one major region (EU, US). Ability to understand and interpret clinical and pre-clinical study results for regulatory strategy. Knowledgeable of clinical trials methodology, protocols, and indications. Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development. Availability for domestic and international travel including overnight stays. Strong interpersonal skills and ability to contribute to a team environment. Professionalism, punctuality, ability to deliver on commitments. Ability to manage multiple tasks in a fast-moving environment and good record-keeping skills. High self-motivation, ability to work and plan independently and in a team. Motivates other members of the project team. Flexible attitude towards work assignments and new learning. Resolves project-related problems and prioritizes workload. Focuses on continuous improvement and making processes more efficient.

Provide regulatory guidance throughout the clinical development life cycle. Compile, coordinate, and review applications to Regulatory Authorities (e.g., CTA/IND, annual reports, marketing applications). Develop and/or review documents for submission to Regulatory Authorities and/or Ethics Committees. Serve as a representative of Global Regulatory Affairs at project team and business development meetings. Oversee and coordinate Regulatory Affairs Specialists for submission targets. Maintain project plans, trackers, and regulatory intelligence tools. Assist in the development of Regulatory Affairs Specialists and other staff. Provide input into regulatory strategy and timeline development for new study opportunities. Participate in maintaining and executing corporate quality initiatives. Stay updated on laws, regulations, and guidelines governing drug development and approval. Provide ICH GCP guidance, advice, and training. Conduct formal presentations to various audiences.