Regulatory Project Assistant

We are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology – it is all we do – combining innovation and expertise to quickly move your medicines from preclinical development into clinical trials. Adaptive and forward-thinking – we guide your therapy through the most critical development milestones from the lab to planning your regulatory and clinical strategy. Our ultimate goal? To help patients.

Position Summary:

This position provides advanced coordination and documentation activities for drug, biologic and medical device regulatory affairs projects, including medical writing and regulatory filings. This position reports to the Associate Director of Regulatory Affairs.

Essential Functions:

• Act as a central contact for the regulatory and medical writing teams for designated project communications, meeting coordination, meeting minutes, correspondence and associated documentation.

• Perform detailed editing and quality control of the clinical and non-clinical sections of regulatory submissions to ensure consistency and accuracy.

• Work in concert with the designated project manager on coordination of documents, including participation on study team calls, maintaining project trackers, tracking document sections and versions to ensure project timeline is maintained.

• Learn and use electronic Common Technical Document (eCTD) publication software to prepare routine regulatory filings.

• Independently maintain a regulatory tracker for each Investigational New Drug Application (IND) or Clinical Trial Application (CTA), proactively gathering information and updating the record of contacts with regulatory agencies.

• Gather, track and maintain project regulatory documents.

• Assist with the development and implementation of efficient regulatory processes and procedures.

• Perform (cross functional) clerical and administrative tasks to support team members with regulatory filings as needed.

• Perform other related duties as assigned.

Job Requirements:

• Bachelor’s degree in a life science or health related field preferred

• Minimum of 4 years’ experience in an administrative role

• Minimum of 3 years’ experience in clinical research or regulatory affairs

• This position requires advanced working knowledge of MS Office products, in particular Word and Project, and Adobe Pro

Required Specialized/Technical Skills:

• Knowledge of ICH guidelines and FDA regulations

• Time management and organizational skills

• Well- organized, detail oriented and adaptable to changes

• Excellent time management skills

• Ability to take initiative and work independently

• Strong interpersonal skills, maintains accountability, and functions as a collaborative team member

Born from the Translational Genomics Research Institute (TGen), TD2 was formed in 2003 as a subsidiary of TGen, and less than two years later, opened its doors on the campus of the Mayo Clinic in Scottsdale, Ariz. In our 17 years of business, we have helped more than 600 biotech and pharma companies, maintaining hundreds of client studies per year. Among them, our team has been involved in more than 600 first-in-man major oncology medicines, including numerous trials that have led to approvals in both rare and large indications.

TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran’s status, gender, sexual orientation, gender identity, or gender expression.