Specialist, Regulatory and Site Activation

Specialist, Regulatory and Site Activation

remote type: Remote locations: Mexico City, Mexico time type: Full time

Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, a global team of experts dedicated to improving lives and transforming the way the world experiences CROs.

Make an Impact as a Specialist, Regulatory & Site Activation at Worldwide Play a key role in helping clinical research studies move from planning to activation by serving as the local expert for regulatory submissions, site activation, and maintenance activities in Mexico. Your expertise will help ensure sites are ready to support important research while maintaining compliance with local regulations and global quality standards.

In this role, you'll partner closely with study teams, investigators, sites, and regulatory stakeholders to drive start-up activities forward, identify and mitigate risks, and keep critical milestones on track. Your ability to navigate local regulatory requirements and build strong site relationships will directly contribute to successful study delivery.

As the primary country-level contact for regulatory and site activation activities, you'll bring together operational excellence, regulatory knowledge, and proactive communication to support study success from site identification through activation and maintenance.

Where You'll Work This is a remote role open to candidates based in Mexico. You will collaborate with global teams across multiple time zones.

What You'll Do

• Lead and support end-to-end site start-up activities from site identification through activation and ongoing maintenance.

• Serve as the primary country-level contact for regulatory and site activation activities across assigned studies.

• Coordinate the collection, review, tracking, and management of site regulatory and essential documents to support timely submissions and approvals.

• Customize and review country-specific regulatory documentation, informed consent forms, patient information materials, labels, and related submission documents.

• Provide guidance on local regulatory requirements, submission strategies, and country-specific timelines to study teams and stakeholders.

• Monitor submission and start-up progress, communicate status updates, and escalate risks with clear mitigation plans.

• Build and maintain strong relationships with investigative sites to ensure efficient completion of start-up and maintenance activities.

• Maintain awareness of evolving local regulations, provide regulatory intelligence, and support interpretation of new requirements.

• Support quality review activities, including local quality control of submission dossiers and translation review when required.

• What You'll Bring

• Bachelor's degree in medical, biological, physical, health, pharmacy, or another related scientific discipline.

• Minimum of 2 years of clinical research experience, preferably in site activation and/or regulatory affairs-related functions.

• Preferred experience within the pharmaceutical and/or CRO industry.

• Good working knowledge of ICH GCP, clinical research regulations, and country-specific regulatory requirements.

• Strong organizational, planning, prioritization, and project coordination skills.

• Ability to proactively identify risks, develop solutions, and manage multiple priorities in a fast-paced environment.

• Excellent written and verbal communication skills with strong interpersonal and stakeholder management abilities.

• Proficiency in English; fluency in the local language required. Additional languages preferred.

• We’re an equal opportunity employer committed to attracting diverse talent and creating an inclusive environment that encourages collaboration and creativity.

• About Us

• We’re a team of clinicians, scientists, and researchers who want to make healthcare better. We were founded on an unwavering commitment to authentic, personalized attention. As CROs continue to evolve, that personalized attention remains important.

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