Responsibilities of the Clinical Trial Regulatory Leader
This position is responsible for managing regulatory Clinical Trial Applications (CTA) submission activities for assigned clinical trials (Phase 1 – Phase 4 spanning five therapeutic areas Oncology, Neuroscience, Cardiovascular and Metabolism, Immunology, and Infectious Disease).
The Regulatory Clinical Trial Application submission manager has experience in regulatory CTA submission regulations, requirements and will be responsible for the execution of the global CTA submission strategy, as well as the quality and completeness of the CTA regulatory submissions for Clinical Trial Applications, throughout the lifecycle of the trial.
The Regulatory Clinical Trial Application submission manager will ensure that the required regulatory intelligence is in place to comply with country-specific requirements and will lead a cross-functional team (CTA Working Group [WG]) that will compile, publish and produce Clinical Trial Authorization Applications and associated CTA lifecycle submissions (e.g., Health Authority responses, amendments, etc.). The CTA submission manager will either submit the CTAs directly to Health Authorities, or facilitate the CTA submission by local personnel in a given country. The CTA submission manager is responsible for interactions with Health Authorities, and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs. The CTA submission manager manages the Output Protection Process for assigned trials and ensures that key events related to the regulatory aspects of clinical trials are tracked in the company-own tracking system. If Clinical Research Organizations are contracted to handle some (or all) aspects as outlined above, the submission manager will be responsible for liaising with and overseeing CRO staff, as required.
Profile of the Clinical Trial Regulatory Leader
- Bachelor’s degree required or equivalent experience
- Science degree or related experience with pharmaceutical or health sciences industry is required
- Knowledgeable with scientific terminology
- Ideal candidate would possess a minimum of 4-6 years experience within regulatory affairs in the pharmaceutical industry
- An understanding of Drug Development, Clinical Trial Authorization Applications, Regulatory Affairs, and associated legal requirements is also required
- Must have strong communication skills (written and verbal), as frequent interactions with Health Authorities, Local Operating Companies, GRA, GCO, and teams occur
- Must have strong project management skills (e.g. planning, prioritization, management of schedules and timelines, detail orientation, strong sense of urgency)
- Ability to lead complex projects and a high degree of problem solving capability required
- Must have a high level of Self-Awareness and Adaptability and strong impact and influencing skills.
- Must have demonstrated the ability to lead multi-functional teams and build strong, productive relationships across the organization
- Fluency in English required, professional level Dutch is a plus
Offer for the Clinical Trial Regulatory Leader
- Challenging projects based on your interests and skills
- Personal follow-up and clear, transparent communication both before and after commencement of employment
- Possibility to follow extra training
- Inspiring network events and legendary after work drinks
- Strong network of industry leading clients
- Expertise within IT, Engineering and Life Sciences
- A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees