Specialist, Regulatory and Site Activation

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

📋 Description

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

• Organize, initiate, and monitor the documents necessary for regulatory submissions.

• Gather, review, and supply requirements from countries, sites, and ethics committees.

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

• Act as the main contact for sites and the regulatory and site activation activities at the country level.

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

• Review and offer guidance on country timelines.

• Inform the Regulatory Affairs Manager and project team about submission status and action plans.

• Collect and conduct initial reviews of site-specific regulatory and essential study documents.

• Monitor regulatory documents by site and country, following up as necessary.

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

• Provide advice on country regulatory strategies.

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

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

• Sustain the regulatory intelligence database for the assigned country.

• Adhere to SOPs, ICH GCP, and relevant regulations.

• Conduct local quality control of submission dossiers as needed.

• Serve as a point of contact for the translation review of submission documents.

• Carry out other assigned responsibilities.

⛳️ Requirements

• A minimum of a 2-year college degree majoring in medical, biological, physical, health, pharmacy, or a related science.

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

• Preferred minimum of one year of experience in the pharmaceutical/CRO industry.

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

• Proficient in the local language.

• Working knowledge of English.

• Strong organizational and management capabilities.

• Excellent planning, strategizing, managing, monitoring, scheduling, and analytical skills.

• Exceptional written and verbal communication abilities.

• Proficiency in Microsoft Word, Excel, and PowerPoint.

• Familiarity with modern digital systems is advantageous.

• Capacity to manage multiple tasks in a dynamic, deadline-driven environment.

• Ability to prioritize and shift between detailed and strategic tasks while ensuring adherence to timelines and quality standards.

• Skill in initiating and building relationships with local investigators and key site personnel.

🏝️ Benefits

• A diverse and inclusive work environment.

• Supportive and collaborative teams.

• Accessible, hands-on leadership.

• Equal employment opportunities.

• Employee experience focused on respect and inclusion.