Associate Manager – Regulatory Affairs / Regulatory Operations North Carolina

Location: North Carolina, USA
Sector: CRO / Clinical Research
Salary:$110,000 – $145,000 depending on experience

About the Opportunity

Quiddity Talent Solutions is supporting a global clinical research organisation with the appointment of an Associate Manager within Regulatory Affairs / Regulatory Operations in North Carolina.

This is an opportunity for an experienced regulatory professional to combine operational regulatory expertise with team leadership, supporting the successful start-up and delivery of clinical trials.

You will provide oversight and guidance to Regulatory Start-Up colleagues, helping ensure regulatory authority and ethics committee submissions, approvals and site identification activities are delivered efficiently and in accordance with ICH-GCP, local regulatory requirements and company procedures.

Key Responsibilities

• Provide day-to-day leadership, mentoring and support to Regulatory Start-Up team members.

• Oversee the preparation, review and submission of Regulatory Authority and Ethics Committee applications.

• Support timely clinical trial approvals and study start-up activities.

• Review essential study documentation including participant information and informed consent materials.

• Provide regulatory input into study start-up timelines and project plans.

• Act as a local regulatory subject matter expert, advising project teams on regulatory and ethics requirements.

• Maintain oversight of regulatory activities, timelines and functional performance metrics.

• Build effective relationships with internal project teams, clients and relevant third-party vendors.

• Support continuous improvement across regulatory start-up processes and ways of working.

• Contribute regulatory expertise to proposals, bid discussions and wider business development activities where required.

About You

We are looking for someone with a strong background in clinical regulatory affairs, regulatory operations or clinical study start-up within the pharmaceutical, biotechnology or CRO environment.

You will ideally bring:

• A degree in clinical sciences, pharmacy, life sciences or a related discipline.

• Strong knowledge of clinical regulatory and study start-up processes.

• Experience supporting or managing Regulatory Authority and Ethics Committee submissions.

• Previous mentoring, supervision or line-management experience.

• Strong project management and organisational skills.

• Excellent communication and stakeholder-management capability.

• A collaborative approach with the confidence to provide regulatory guidance to cross-functional teams.

This is a strong opportunity for someone looking to combine hands-on regulatory expertise with increased leadership responsibility within an international clinical research environment.