Regulatory Start Up Associate

Novotech Global•Charleston, SC

About The Position

The Regulatory Start-Up Associate (RSA) is responsible for the planning, preparation, and review of country- and site-level ethics and regulatory authority submissions during the start-up phase of clinical trials, and, where applicable, throughout maintenance and close-out. They ensure that all submissions comply with ICH-GCP guidelines and local regulatory requirements to support timely trial approvals. The RSA has an action-oriented mindset to proactively address challenges and advance start-up activities. The ability to balance stakeholders is essential, considering ethical, cultural, and organizational needs. Strong planning and alignment skills ensure activities are structured and adaptable to change.

Requirements

Graduate in a clinical, pharmacy or life sciences related field; and or
At least 1-2 years of related experience in either a CRO, pharmaceutical or clinical/hospital environment.
At least 1-2 years Regulatory Start-up experiences in clinical industry

Responsibilities

Serve as the primary point of contact for the Regulatory Start Up Manager (RSM) and/or Project Manager (PM) and/or sites for country and site level start up activities on allocated projects.
Provide expertise and guidance to RSM/PM on country and local regulations and practices, keeping abreast of developments and changes in regulations, guidelines and practices surrounding clinical trial approvals in relevant countries.
Work within the scope of the Regulatory Start Up plan or other applicable project plan, relevant SOPs, and ICH-GCP.
Provide country and site level information on submission deadlines and timeline metrics for local Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies as appropriate.
Works within forecasted submission/approval timelines and ensures they are complied with, updating appropriate systems accurately and in a timely manner, including planned and actual dates of submissions/approvals.
May serve as a point of contact with investigative sites for Regulatory Authority, Ethics Committees/Review Boards and other local authority related activities.
Prepare and submits Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required.
Ensure submission packages are accurate and complete per local requirements.
Review and follow-up on comments/questions raised by reviewing bodies and advise/contribute to response. Submit response with Client approval within timeframe.
Follow submission, application to approval.
May prepare and submit ongoing amendments, notifications, safety reports and study related materials required by Regulatory Authorities, Ethics Committees/Review Boards and other local authorities as per local requirements.
Perform country and site Informed Consent Form (ICF) customisation in line with local requirements.
Initiate translation of submission documents as applicable and review translated documents before submission.
Support Clinical Contracts Specialists (CCS) to review and finalise the Country Master budget.
Adapt site budgets from Country Master budgets and coordinate site budget and Clinical Trial Agreement (CTA) negotiations with sites and/or CCS for finalisation and approval from PM/RSM and client if required.
Review and approve proposed packaging and labelling for clinical trial material.
Prepare and submits import/export license applications and management of licenses and custom clearance thereafter if required.
Register project onto an official clinical trial registry as agreed to with Client and update status as required.
Submit regulatory and ethics documents and relevant study correspondence to the trial master file and ensures accuracy and completeness of these documents.
Serve as an independent essential document reviewer.
Escalates issues to RSM/PM that may delay or impact project start up timelines and deliverables; provides rationale for delays and contingency plan to mitigate impact.
Ensure all clinical trial management systems are current and up to date at all times with all relevant trial data.
Understand the responsibilities of Novotech as a service provider in the pharmaceutical and biotech industry and ensure all communications with external and internal customers present a positive professional image of the company.
Undertake additional responsibilities assigned by your Line Manager.