Regulatory Clinical Trial Application Submission M
Alex Tosney is recruiting for a Regulatory Clinical Trial Application Submission Manager to join a pharmaceutical organisation based in Basel for a 6 month contract.
The main purpose of the role will be to manage regulatory Clinical Trial Applications (CTA) submission activities for assigned clinical trials (Phase 1 - Phase 4 mainly in the Pulmonary Hypertension therapeutic area).
Further duties include to:
- 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.
- Submit the CTAs directly to Health Authorities, or facilitate the CTA submission by local personnel in a given country.
- Responsibility for interactions with Health Authorities, and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs.
- Manager 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.
- Responsible for liaising with and overseeing CRO staff, as required.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- 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 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.
For more information or to apply for this position, please contact Alex Tosney on +41 (0) 417276793 or email atosney@ckqls.ch. Please quote reference 47043 in all correspondence.
