Regulatory Compliance Specialist

This is a fully remote position, open to applicants in Serbia.

📋 Description

• Oversee regulatory compliance initiatives for designated projects and act as the primary Regulatory Compliance representative within global project teams.

• Create and uphold Essential Document Review Plans, assess requirements, country-specific checklists, and project templates to facilitate study start-up activities.

• Evaluate, analyze, and authorize essential document packages to ensure adherence to regulations, SOPs, guidelines, and project specifications.

• Collaborate with Site Activation, Regulatory Affairs, Site Contracts, Project Leadership, and sponsors to prioritize document reviews and ensure coordinated study start-up timelines.

• Detect documentation deficiencies, communicate necessary corrective measures, and drive prompt resolution of issues prior to document approval.

• Track and manage project tools for monitoring document review progress and approval status.

• Organize and submit sanctioned essential documents for filing in the Trial Master File, as needed.

• Provide training and guidance to sponsor and CRO personnel regarding the collection, maintenance, and compliance of essential documents.

• Raise quality concerns and participate in ongoing compliance and quality oversight throughout projects.

⛳️ Requirements

• A university degree is preferred, ideally in a Life Science field, along with a minimum of 3 years of relevant experience, including at least 1 year in a similar position; or an equivalent combination of education and experience involving 4 years in related roles with 2 years in a similar capacity.

• Familiarity with ICH, GCP, FDA, and/or EU regulatory standards, as well as local regulations applicable to the role.

• Proven experience in reviewing, managing, and maintaining essential study documents and regulatory compliance processes.

• Strong organizational, planning, scheduling, and time management skills, with the capability to juggle multiple priorities in a dynamic environment.

• Excellent problem-solving abilities, sound judgment, and the capacity to recognize situations that necessitate escalation or supervisory intervention.

• Strong interpersonal and communication skills, with the ability to present information clearly and succinctly.

• Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint, as well as experience with electronic document management systems.

• Proficiency in written and spoken English.

🏝️ Benefits

• Equal employment opportunities.

• Diverse and inclusive work environment.

• Culture focused on collaboration and creativity.

• Remote work arrangement.

• No travel required.