Senior Regulatory and Start Up Specialist, Mexico
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Job Description
Senior regulatory specialist launching clinical trials for Precision for Medicine in Mexico. Managing submissions, essential documents, site activation and regulatory compliance.
Responsibilities:
- Deliver timely, high-quality site activation readiness for assigned Mexico sites and mitigate risks
- Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees and other local bodies
- Interact with Competent Authorities and Ethics Committees and handle responses
- Provide submission updates to Start Up/Regulatory Leads and Project Managers/teams
- Maintain project plans, trackers and regulatory intelligence tools
- Support study-specific start-up plans, IMP release requirements and essential document review criteria
- Partner with site CRAs to align communication and secure site collaboration
- Prepare, review and manage essential documents for site activation and IMP release
- Customize country/site-specific Patient Information Sheets and Informed Consent Forms
- Coordinate document translations
- Communicate with Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts teams
- Act as subject matter expert for site activation critical-path data, timelines, contracts and budget requirements
- Support study budget negotiations and investigator contract execution
- Maintain knowledge of local clinical trial laws and regulations and distribute regulatory knowledge
- Maintain audit/inspection readiness and file documents in the relevant TMF
- Support pre-study site visits, feasibility outreach, country start-up summaries, training, mentoring and client updates as required
- Perform other duties assigned by management
Requirements:
- Bachelors’ degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience
- 3.5 years or more as a Regulatory or Site Start-Up specialist in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies
- Professional-level English proficiency
- Fluency in English and the local language of the country where the position is based
- Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail
- Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements
- Excellent communication, organizational, presentation and interpersonal skills
- Ability to prioritize workload and meet deadlines
- Ability to work independently in a fast-paced environment
- Excellent computer skills
- Occasional travel may be required
- Must be legally authorized to work in the country of employment without employer sponsorship
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