Specialist, Regulatory Compliance (Serbia)

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.

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!

• →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.

• 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. 

To view our other roles, check out our careers page at Discover a world of difference at Worldwide! 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’re on a mission to hire the very best and 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.