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Senior Research Innovation Analyst
DasaRegulatory Affairs Analyst managing clinical research regulatory processes at Dasa. Ensuring compliance with Brazilian clinical research legislation while coordinating with sponsors and internal departments.
About the role
Key responsibilities & impact- Work on regulatory processes for clinical research, including initial submissions and amendments to CEP/CONEP (research ethics committees);
- Maintain organized regulatory documentation for studies;
- Serve as an interface with sponsors, CROs and internal departments;
- Monitor regulatory pending items and track deadlines;
- Support audits and inspections, ensuring continuous regulatory compliance of the studies.
Requirements
What you’ll need- Bachelor's degree in health sciences, business administration or law;
- Previous experience in Clinical Research Regulatory Affairs;
- Knowledge of Brazilian clinical research legislation (ANVISA, CEP/CONEP);
- Experience with Plataforma Brasil;
- Intermediate to advanced English for reading and interacting with sponsors;
- Experience with sponsor‑initiated multicenter studies; experience with regulatory inspections and audits.
Benefits
Comp & perks- Meal support: Meal voucher/food voucher or on-site cafeteria (depending on location);
- Health support: Private health insurance and life insurance;
- Development support: Universidade Dasa, Development and Career Cycle, Technology Academies/PMAX and the 'Crescer' program within Dasa;
- Other: Transportation voucher and performance bonus (PPR);
- Health program based on five pillars: Spiritual — yoga; Physical — TotalPass, primary care clinic, discounts on exams and vaccines; Intellectual — Universidade Dasa; Relational — UAU benefits club and SESC benefits; Emotional — telepsychology.
ATS Keywords
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Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory processesregulatory documentationregulatory complianceclinical researchregulatory inspectionsauditsmulticenter studiesBrazilian clinical research legislationANVISACEP/CONEP
Soft Skills
organizational skillscommunication skillsinterpersonal skillsdeadline management
Certifications
Bachelor's degree in health sciencesBachelor's degree in business administrationBachelor's degree in law