Regulatory and Site Activation Specialist

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

📋 Description

• Assist with regulatory submissions, site activation, and ongoing maintenance for awarded projects.

• Act as the main point of contact for sites throughout the start-up process, from identification to activation and ongoing maintenance.

• Serve as the internal country-level liaison for regulatory and site activation activities.

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

• Review 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 country, following up with sites and internal team members as necessary.

• Identify risks at the country and site levels, and develop mitigation strategies.

• Offer advice on suitable regulatory strategies for the country.

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

• Provide updates on evolving regulatory requirements and assist in interpreting new regulations.

• Manage the regulatory intelligence database for the designated country.

• Ensure local quality control of submission dossiers when required.

• Assist in the review of translations for submission documents as needed.

• Carry out other assigned responsibilities.

⛳️ Requirements

• A minimum of a 2-year college education with a major focus on medical, biological, physical, health, pharmacy, or other related sciences.

• At least 2 years of experience in clinical research, ideally in site activation and/or regulatory-related roles.

• Preferred minimum of one year of prior experience within the pharmaceutical/CRO sector.

• Solid understanding of ICH GCP, relevant clinical research conduct guidelines, and country regulations.

• Proficiency in the local language.

• Working knowledge of English.

• Competence in Microsoft Word, Excel, and PowerPoint.

• Excellent organizational, planning, management, monitoring, scheduling, and evaluation skills.

• Outstanding written and verbal communication abilities.

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

• Capability to manage multiple tasks effectively.

• Understanding of local cultural norms and healthcare systems at the country level.

• Ability to establish and nurture relationships with local investigators and key personnel at sites.

• Skill in prioritizing and transitioning between detailed and strategic tasks while ensuring timely delivery and quality.

• Familiarity with SOPs, ICH GCP, and applicable regulations.

🏝️ Benefits

• Equal employment opportunities.

• A diverse and inclusive work environment.

• Supportive and collaborative teams.

• Opportunities for professional growth and development.