Clinical Trial Regulatory Advisor

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

📋 Description

• Offer regulatory and technical assistance for designated regulatory tasks.

• Review and finalize key core documents necessary for site initiation, regulatory, and core submissions, from site startup to study-end submissions.

• Execute CTRA operational deliveries and lead regulatory activities for assigned project tasks.

• Review clinical trial study core documents to ensure regulatory compliance.

• Assist in preparing technical components of regulatory core submissions, including EU Clinical Trial Regulation Parts I and II.

• Contribute to and support interactions with regulatory agencies.

• Oversee and manage daily regulatory activities in accordance with timelines, scope, budgets, and strategies.

• Serve as a subject matter expert and resolve project-related issues.

• Act as regulatory support within multidisciplinary project teams.

• Identify and report on process and risk areas.

• Ensure compliance and accuracy with relevant quality standards.

• Stay updated on applicable regulations, laws, and guidelines related to pre- and post-market healthcare product requirements.

• Conduct activities in line with corporate and divisional policies, standard operating procedures, and operating guidelines.

• Carry out additional duties as assigned by management.

⛳️ Requirements

• A minimum of a BA or BS is preferred.

• Experience in working with applicable GxPs, including GVP, GCP, and ISO 14155.

• Exceptional presentation, documentation, influencing, and interpersonal skills in both written and spoken English.

• A team-oriented mindset.

• Proficient in Microsoft Office Suite, web-based systems, voicemail, email, and Internet applications.

• Equivalent experience, skills, and/or education may be taken into account.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Reasonable accommodations provided, when appropriate, for employees or applicants with disabilities.