Senior Regulatory and Start Up Specialist (Brazil)
On-siteRio de Janeiro, Rio de Janeiro, Brazil
Job Summary
Conduct initial and subsequent clinical trial submissions to Competent Authorities and IRB/Ethics Committees, including Informed Consent Form review and adaptation. Prepare Clinical Trial Application Forms and submission dossiers, manage essential document collection, and facilitate translations for local regulatory requirements. Act as Subject Matter Expert for site start-up activities, support sites on IRB/EC submissions, and partner with Site Contract Management for budget and contract negotiations. Maintain audit readiness, track project timelines, and mentor less-experienced staff on local regulations and internal procedures. Provide activation readiness updates to the project team and participate in feasibility assessments or client presentations as required.
Required Qualifications
- Bachelors' degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience
- 3.5 years or more as a Regulatory or SU specialist in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies
- Ability to communicate both verbally and in writing at the English proficiently (Professional level)
- Excellent communication and organizational skills are essential
- Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required
- Fluency in English and for non-English speaking countries the local language of country where position based
- Ability to prioritize workload to meet deadlines
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information
- Excellent organizational skills
- Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located
- Ability to work independently in a fast-paced environment with a sense of urgency to match the pace
- Must demonstrate excellent computer skills
- Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
- Flexible attitude with respect to work assignments and new learning
- Occasional travel may be required
Desired Qualifications
- Relevant regulatory and site start-up (feasibility, contract negotiations, CA/EC/IRB submissions) experience for the particular country
- Experience using milestone tracking tools/systems
- Can assist junior SU specialists in problem resolution
- Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science
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