Specialist, Regulatory Compliance (Serbia)

Worldwide Clinical Trials; United States; À distance; USD 80 000 - 120 000; Plein temps

Résumé du poste

Worldwide Clinical Trials is seeking a Specialist, Regulatory Compliance to ensure study documentation meets high-quality regulatory standards and to support timely study start-up across global teams.

The role emphasizes ownership of document review processes, guidance to project teams, and ongoing compliance with ICH/GCP, FDA/EU regulations, and internal SOPs. This remote position offers collaboration across time zones and no travel.

Qualifications

• University degree preferred with 3+ years in regulatory roles.
• Experience reviewing essential study documentation and maintaining regulatory compliance.

Responsabilités

• Lead regulatory compliance activities for assigned projects and serve as the primary Regulatory Compliance representative within global project teams.
• Develop and maintain Essential Document Review Plans, review requirements, country-specific checklists, and project templates to support study start-up activities.
• Review, assess, and approve essential document packages to ensure compliance with applicable regulations, SOPs, guidelines, and project requirements.
• Partner with Site Activation, Regulatory Affairs, Site Contracts, Project Leadership, and sponsors to prioritize document reviews and support synchronized study start-up timelines.
• Identify documentation gaps, communicate corrective actions, and drive timely resolution of issues before document approval.
• Monitor and maintain project tracking tools to provide visibility into document review progress and approval status.
• Prepare and submit approved essential documents for Trial Master File filing, as applicable.
• Support training and guidance for sponsor and CRO personnel on essential document collection, maintenance, and compliance requirements.
• Escalate quality concerns promptly and contribute to continuous compliance and quality oversight across projects.

Connaissances

Regulatory compliance

Documentation management

Time management

Communication

Formation

University degree preferred

Outils

Microsoft Office Suite

Electronic document management systems

Description du poste

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.Join us!

Make an Impact as a Specialist, Regulatory Compliance at Worldwide

In this global role, you will play a critical part in ensuring essential study documentation is reviewed, approved, and maintained to the highest quality standards before study sites are activated. Your work will directly support the timely start-up of clinical research studies and help maintain compliance with applicable regulations, industry standards, and internal procedures.

Working closely with cross-functional teams and stakeholders around the world, you will provide expertise in regulatory compliance and essential document management. You will help drive quality, consistency, and efficiency across projects while contributing to successful study start-up activities.

This is an opportunity to take ownership of document review processes, provide guidance to project teams, and make a meaningful impact on the delivery of clinical research programs.

Where You’ll Work

This is a remote role open to candidates based in Serbia. You will collaborate with global teams across multiple time zones.

No travel is required for this position.

What You’ll Do

• Lead regulatory compliance activities for assigned projects and serve as the primary Regulatory Compliance representative within global project teams.
• Develop and maintain Essential Document Review Plans, review requirements, country-specific checklists, and project templates to support study start-up activities.
• Review, assess, and approve essential document packages to ensure compliance with applicable regulations, SOPs, guidelines, and project requirements.
• Partner with Site Activation, Regulatory Affairs, Site Contracts, Project Leadership, and sponsors to prioritize document reviews and support synchronized study start-up timelines.
• Identify documentation gaps, communicate corrective actions, and drive timely resolution of issues before document approval.
• Monitor and maintain project tracking tools to provide visibility into document review progress and approval status.
• Prepare and submit approved essential documents for Trial Master File filing, as applicable.
• Support training and guidance for sponsor and CRO personnel on essential document collection, maintenance, and compliance requirements.
• Escalate quality concerns promptly and contribute to continuous compliance and quality oversight across projects.

What You’ll Bring

• University degree preferred, ideally in a Life Science discipline, with at least 3 years of relevant experience including 1 year in a similar role; or an equivalent combination of education and experience including 4 years in comparable positions and 2 years in a similar role.
• Knowledge of ICH, GCP, FDA and/or EU regulatory requirements, as well as applicable local regulations.
• Experience reviewing, managing, and maintaining essential study documentation and regulatory compliance processes.
• Strong organizational, planning, scheduling, and time management skills with the ability to manage multiple priorities in a fast-paced environment.
• Excellent problem-solving skills, sound judgment, and the ability to identify situations requiring escalation or supervisory input.
• Strong interpersonal and communication skills with the ability to present information clearly and concisely.
• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint, and experience working with electronic document management systems.
• Proficiency in written and spoken English.

We love knowing that someone is going to have a better life because of the work we do.

For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative,innovative,and successful. We’reon a mission to hire thevery bestand are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law .