Regulatory Start Up Associate II

Novotech; South Dakota; On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Flexible working options

Paid parental leave

Wellness programs

Job summary

A leading clinical research organization is seeking a Regulatory Start Up Associate in South Dakota. The role involves planning, preparation, and review of regulatory authority applications during project start-up to ensure timely clinical trial approvals. Candidates must have a degree in clinical or life sciences and relevant experience. This position offers flexible working options and a supportive work environment.

Qualifications

• 1-2 years of related experience in CRO, pharmaceutical or clinical/hospital environment.
• Responsible for quality start-up deliverables at country and site level.
• Knowledge of ICH-GCP and local regulatory requirements.

Responsibilities

• Serve as primary contact for RSM and/or PM during start-up on allocated projects.
• Prepare and submit Central EC/IRB applications and local EC/Governance applications.
• Ensure submission packages are accurate and complete per local requirements.

Skills

Regulatory knowledge

Project management

Attention to detail

Education

Graduate in clinical, pharmacy or life sciences

Job description

This range is provided by Novotech. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$70,000.00/yr - $95,000.00/yr

About the Role
The 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.

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.

Experience and Qualifications

• Graduate in a clinical, pharmacy or life sciences related field.
• At least 1-2 years of related experience in either a CRO, pharmaceutical or clinical/hospital environment.
• Responsible for quality start-up deliverables at the country and site level; follows project requirements and applicable country rules, with moderate oversight from the RSM or PM.

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.

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.

Novotech is an Equal Employment Opportunity employer and welcomes applications from diverse candidates.