Regulatory & Site Activation Specialist

This is a fully remote position, open to applicants in Argentina, +1 more country.

📋 Description

• Act as the subject matter expert and main point of contact for regulatory submissions, site activation, and ongoing maintenance.

• Facilitate the complete process of site start-up, from site identification through to activation and maintenance.

• Serve as the primary country-level liaison for regulatory and site activation efforts in designated studies.

• Tailor country-specific patient information sheets, informed consent documents, labels, and local regulatory paperwork.

• Evaluate and provide guidance on country timelines.

• Communicate the status of submissions and action plans to the Regulatory Affairs Manager and project team.

• Gather, receive, and conduct initial reviews of study-specific site regulatory and essential documents.

• Monitor regulatory documents by site and/or country and follow up as necessary.

• Identify risks at the country/site level and formulate mitigation strategies.

• Offer advice on suitable country regulatory strategies.

• Maintain communication with sites to ensure prompt completion of start-up and maintenance tasks.

• Provide updates regarding changing regulatory requirements and assist in interpreting new regulations.

• Keep the regulatory intelligence database updated for the assigned country.

• Adhere to Standard Operating Procedures (SOPs), ICH Good Clinical Practice (GCP), and relevant regulations.

• Conduct local quality control of submission dossiers when necessary.

• Act as the contact for translation-review of submission documents as needed.

• Carry out other assigned responsibilities.

⛳️ Requirements

• At least a 2-year college degree with a major in medical, biological, physical, health, pharmacy, or another related field.

• Minimum of 2 years of experience in clinical research, ideally in site activation and/or regulatory functions.

• Preferred minimum of one year of prior experience in the pharmaceutical or Clinical Research Organization (CRO) sector.

• Solid understanding of ICH GCP, pertinent clinical research conduct guidelines, and country-specific regulations.

• Proficient in the local language; working knowledge of English is essential.

• Strong skills in organization, planning, strategy, management, monitoring, scheduling, and evaluation.

• Exceptional written and verbal communication abilities.

• Proactive in identifying issues and anticipating solutions.

• Knowledgeable about country-level cultural norms and local healthcare systems.

• Capable of building relationships with local investigators and key site personnel.

• Skilled in prioritizing and transitioning between detailed and strategic tasks while ensuring timelines and quality are upheld.

• Team-oriented work approach.

• Strong interpersonal abilities in a fast-paced, deadline-driven, and dynamic environment.

• Competent in managing multiple tasks in a rapidly changing setting.

• Proficient in Microsoft Word, Excel, and PowerPoint.

• Familiarity with contemporary digital systems is advantageous.

🏝️ Benefits

• A diverse and inclusive workplace.

• Supportive and collaborative teams.

• Accessible leadership.

• Equal employment opportunities.

• Employee experiences centered on respect and inclusion.