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.
- 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.).
- Submit the CTAs directly to Health Authorities, or facilitate the CTA submission by local personnel in a given country.
- Responsible for interactions with Health Authorities, and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs.
- Manage 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.
- Identify and respond proactively to issues, problems, or opportunities as it relates to the leading the CTA workgroup. Independently identifies the need for and collects information (from CTA working groups, GCO, HA-interactions, Local Operating Companies, Regional offices etc.) to better understand and resolve issues/challenges and seize opportunities.
- Integrate information from a variety of sources, detects trends, associations, and cause-effect relationships and communicates to supervisor, CTA working group and others as appropriate.
- Propose relevant options for addressing problems or opportunities to supervisor.
- Make decisions independently for day-to-day activities of CTA workgroup. Decisions as they relate to changing processes that affect external stakeholders require consultation with supervisor and CTA Process Owner.
- Relations with: Regulatory Affairs staff within the global, regional, and therapeutic area organizations, Cross-functional CTA working group team members, Local clinical trials staff, Health Authorities and CROs (if applicable)
- Bachelor's degree or equivalent by experience; Science degree or related experience with pharmaceutical or health sciences industry is required; knowledgeable with scientific terminology.
- 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
- Strong communication skills (written and verbal), as frequent interactions with Health Authorities, Local Operating Companies, GRA, GCO, and teams occur.
- 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.
- High level of self-awareness and adaptability and strong impact and influencing skills.
- Ability to lead multi-functional teams and build strong, productive relationships across the organization.
- Able to work independently, strong initiative. May have to work remotely from supervisor.
- An attractive salary in line with your experience and skills.
- Fringe benefits including, medical insurance, pension plan and a care plan.
- A supporting environment.
- Respect for the life-work balance.
- Career planning.
- A focus on professional and personal growth through training and coaching.
- Room for personal engagement to help shape our company's future.