Regulatory Affairs Associate-Romania

Description

The Regulatory Affairs Associate will support the preparation, tracking, and coordination of Ethics Committee (EC) and Regulatory Authority (RA) submissions. Under supervision, the Associate will assist the Regulatory Affairs team in ensuring that clinical trial submissions comply with applicable regulations and internal timelines.

More specifically, the Regulatory Affairs Associate must:

• Assist in the compilation and preparation of documentation required for EC and RA submissions.
• Support the tracking of submission timelines and maintain up-to-date regulatory trackers and databases.
• Assist in the preparation and submission of initial applications, amendments, and notifications under supervision.
• Help coordinate with IRB/IEC and internal teams to collect required documentation.
• Review and format documents for consistency and completeness prior to submission.
• Assist in adapting country-specific informed consent forms based on master templates.
• Coordinate translation requests and track deliverables from external vendors.
• Help submit documents to the Trial Master File (TMF) and participate in TMF reconciliation activities for assigned sections.
• Perform administrative tasks including document archiving, status reporting, and follow-up with sites or vendors as directed.
• Support regulatory specialists in the review and submission of SUSARs, as required by study scope.
• Stay informed of basic regulatory guidelines applicable to the assigned countries.
• Participate in internal meetings and training sessions as required.

Requirements

• Bachelor’s degree (or equivalent) in a scientific discipline
• 0-2 years in clinical regulatory affairs in the pharmaceutical, biotechnology and/or CRO industry; experience preparing and submitting IRB/IEC packages and /or CTAs
• Knowledge of applicable regional / national country regulatory guidelines and IRB/IEC regulations is an asset.
• Excellent knowledge of Microsoft Office suite
• Additional languages represent an asset
• Basic understanding of clinical trial processes and regulatory requirements is an asset.
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
• Fluency in English (oral and written); additional languages are an asset.
• Strong attention to detail and organizational skills.
• Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
• Willingness to learn and develop regulatory expertise under guidance.

Our company

The work environment

At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. 

In this position, you will be eligible for the following perks: 

• Permanent full-time position
• Flexible schedule
• Vacation
• Home-based position
• Ongoing learning and development

About Indero  

Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.

Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in Romania.