Senior Regulatory Start-up Manager (RSM)

About the role

Premier Research is looking for a Senior Regulatory Start-up Manager (RSM) to join our Global SSU team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
• We are Built by You. Your ideas influence the way we work, and your voice matters here.
• We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Together, we are Built for Biotech. Join us and build your future here.

What you will be doing :

• Responsible for developing the Regulatory & start-up submission project plan.  Is the driver for CA, EC and LEC submission as well other boards/evaluating bodies, import and export licenses, where applicable.
• Responsible for the coordination and strategic planning of all required initial study submissions, as well as for the submission of the changes (substantial and non-substantial) occurred during the lifecycle of clinical study as required.
• Responsible for the pertinent notifications throughout the trial (e.g. First patient-in, End of Trial)
• Is the liaison with the Sponsor regarding approval and collection of all core documents, country submission packages and commination and adherence to timelines and deliverables
• For interventional clinical studies running in EU, RSL is responsible for the strategic planning, coordination and actual submission via Clinical Trial Information System (CTIS) in collaboration with Sponsor and SSUAs as defined in company procedures.
• Responsible for identifying & communicating country timelines to our clients and project teams
• Responsible for identifying & communicating risks and contingency plans related to start up activities to our clients and project teams
• Generates and obtains appropriate Sponsor approval for master core documentation e.g. Submission cover letters and applications forms etc.
• Review master IP labels and provides feedback on its potential acceptability to regulatory authorities including issues related to country adaptation
• Oversees the regulatory approval of IP release
• Ensures continuous improvement of quality in all Regulatory and Start-up components at the project level (clinical trial applications, essential document collection, communication to Competent Authority and Ethics Committees, etc.).
• Keeps abreast of trends and updates on guidelines and regulations related to the clinical study start-up and submissions.

What we are searching for:

•  Minimum of 8 years professional experience, including at least 6 years of previous experience as RSM
• Experience in managing submission of complex trials, different IP types and different phases, globally
• Strong working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and start-up procedures.
• Strong Knowledge of ICH / GCP regulations / country specific regulations as applicable
• Ability to work accurately and to interpret the relevant directives and guidelines
• Strong working knowledge of professionally recognized tools for planning and management of scope, timeline, resources, and budget.
• Experience in coaching/mentoring other RSMs