Hobson Prior are looking for a Regulatory CTA Sub Manager to join a top pharmaceutical company who focus on changing the way diseases are dealt with, interpreted and prevented to transform the lives of individuals.
- 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 CTA submission manager will either 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.
- Accountable for liaising with and overseeing CRO staff when required.
- Must have strong communication skills both written and verbal.
- Must have strong project management skills (e.g. planning, prioritization, management of schedules and timelines, detail orientation, strong sense of urgency).
- Must be able to work self-sufficiently with strong initiative.
- Ability to lead complex projects and a high degree of problem solving capability is required.
- Bachelor's degree required or equivalent experience.
- Science degree or related experience with pharmaceutical or health sciences industry is required, with knowledge of scientific terminology.
- Minimum of 4-6 years’ experience within regulatory affairs in the pharmaceutical industry.
- 5+ years preparing and making Clinical Trial Applications to Health Authority within the EU and overseeing and project managing global studies.
- Good knowledge of Drug Development, Clinical Trial Authorization Applications, Regulatory Affairs, and associated legal requirements is required.
- Previously demonstrated the capability to lead multi-functional teams and build strong, productive relationships across the organization.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.