Description
The successful candidate will be responsible for managing regulatory aspects for assigned clinical trials (Phase 1 - Phase 4 spanning five therapeutic areas Oncology, Neuroscience, Cardiovascular and Metabolism, Immunology, and Infectious Disease).You will bring to this your experience in clinical trial regulations and regulatory requirements and will be responsible for the overall trial submission strategy, as well as the quality and completeness of regulatory submissions for Clinical Trial Applications, throughout the lifecycle of the trial.
You will ensure that the required regulatory intelligence is in place to comply with country-specific requirements and will lead a cross-functional team that will compile, publish and produce Clinical Trial Authorization Applications and associated CTA lifecycle submissions.
The selected candidate will be responsible for interactions with Health Authorities, and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs.
Essential:
- Science degree or related experience with pharmaceutical or health sciences industry is required
- Minimum of 4-6 years experience within regulatory affairs in the pharmaceutical industry.
- Stong communication skills (written and verbal), as frequent interactions with Health Authorities, Local Operating Companies, GRA, GCO, and teams occur.
- Strong project management skills.
- 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.
- Demonstrated the ability to lead multi-functional teams and build strong, productive relationships across the organization.
- Must be able to work independently, strong initiative.