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, Essential Document collection, and quality assurance. Prepare submission dossiers and manage interactions with regulatory bodies to secure authorizations while maintaining audit readiness. Act as Subject Matter Expert for site start-up activities, mentor junior staff, and customize country-specific patient information sheets. Partner with sites and contract management to negotiate budgets and ensure alignment on activation readiness. Maintain project trackers, regulatory intelligence tools, and local clinical trial law knowledge to mitigate risks and support feasibility assessments.
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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