Job Description

About the role:

The Senior Regulatory Start Up Associate is primarily responsible for planning, preparation, review of country and site level ethics and regulatory authority applications and submissions during project start-up, in compliance with ICH-GCP and local regulatory requirements, to ensure timely clinical trial approval.

Minimum Qualifications & Experience:

Graduate in a clinical, pharmacy or life sciences related field. At least 3-5 years of related experience in either a CRO, pharmaceutical or clinical/hospital environment.

Responsibilities:

Serve as the primary point of contact for the Regulatory Start-Up Manager (RSM) and/or Project Manager (PM) during start-up on allocated projects. Provide expertise and guidance to RSM and/or 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 serve as a point of contact for Regulatory Authorities, Ethics Committees/Review Boards and other local authorities. 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. Escalate any issue to the RSM and/or PM and provides rationale for submission/approval delays, and contingency plan to mitigate impact. Perform country and site Informed Consent Form (ICF) customization in line with local requirements. Initiate translation of submission documents as applicable and review translated documents before submission. 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 and performs 2nd review of Activation Forms for IP release if required. Where applicable, may act as a Country Lead for projects with no RSM. At least 3-5 years Regulatory Start-up experiences in clinical industry. Responsible for development of master and country ICFs, study specific forms and other documents required for Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required. Participate in company start-up initiatives, contributing to development and maintenance of regulatory start-up processes, tools and SOPs. Identify areas of inefficiency in process and make recommendations for improvements. Assist with RSA training in the development and delivery of training in conjunction with Learning and Development Manager and serve as a mentor to junior RSAs. Serve as the local subject matter expert on specialized aspects of regulatory and start -up activities.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.


We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.


We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.