Regulatory Start Up Manager
Bring your Passion to Premier!
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.
Working at Premier Research means being an individual - you will be recognised for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.
We’re looking for a Regulatory Start-Up Manager to join our team! This is a permanent role to be either office based or home based in Spain.
Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
You will be accountable for:
- Successfully developing the Regulatory & start-up submission project plan and driving CA, EC and LEC submissions as well other boards/evaluating bodies, import and export licenses.
- Pertinent notifications throughout the trial (e.g. First patient-in, End of Trial)
- Serving as liaison with the Sponsor regarding approval and collection of all core documents, country submission packages and adherence to timelines and deliverables
- Identifying and communicating country timelines to our clients and project teams as well as risks and contingency plans related to start up activities to our clients and project teams
- Overseeing the site contract execution process in the studies that a Contracts Lead is not assigned.
- Obtaining the EudraCT number where delegated by Sponsor
- Generating and obtaining the appropriate Sponsor approval for master core documentation e.g. Submission cover letters and EudraCT xml etc.
- Reviewing master IP labels and provides feedback on its potential acceptability to regulatory authorities, including issues related to country adaptation
You will need this to be considered:
- Education to university degree level in pharmacy, medicine or related natural sciences
- Previous professional experience, including previous experience in Regulatory or Start-up functions at a ideally a Global level along with Prior hands-on experience in the submission of clinical trial applications
- Proven ability to perform the role of Regulatory Lead (RL) for newly awarded studies containing countries from the same region, and may take a multi-region study in Start-up under supervision, or maintenance studies independently
- Working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and start-up procedures
- Ability to read, write, and speak fluent English; fluent in host country language