Senior Regulatory Affairs Analyst
OneTrust
full-time
Posted on:
Location Type: Hybrid
Location: São Paulo • Brazil
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Job Level
About the role
- Develop strategic analyses of business information from a regulatory perspective;
- Prepare and submit regulatory dossiers (New Products, Renewals, Line Extensions, and Variations);
- Ensure robustness in responses to regulatory requests;
- Conduct regulatory assessments of new business opportunities in collaboration with the New Business team;
- Maintain ongoing interactions with regional regulatory team members, Medical Affairs, Access, and Marketing;
- Participate in product launch teams;
- Monitor the company's regulatory submissions and approvals;
- Review promotional materials for the therapeutic area;
- Responsible for regulatory and competitive intelligence in the assigned therapeutic area;
- Attend meetings with external entities and internal meetings with different departments, contributing and sharing expertise;
- Interact with the Health Authority in meetings or via email;
- Monitor publication of new legislation, evaluate impacts, risks and opportunities, and develop a robust implementation plan;
- Ensure compliance with regulations and interpretations issued by the regulatory agency;
Requirements
- Bachelor's degree in Pharmacy, Biology, Biochemistry, Microbiology, Chemistry, or related fields;
- Solid professional experience in regulatory affairs, preferably with product registrations and pipeline management;
- Strong knowledge and experience with Pharmaceutical Industry regulations;
- Proficiency in Microsoft Office;
- Strong problem-solving skills;
- Advanced English (Spanish desirable);
Benefits
- Health benefits
- Hybrid work
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory affairsregulatory submissionsregulatory assessmentsproduct registrationspipeline managementcomplianceregulatory dossierscompetitive intelligencetherapeutic area knowledgeproblem-solving
Soft Skills
strategic analysisinterpersonal communicationcollaborationcontributionexpertise sharing
Certifications
Bachelor's degree in PharmacyBachelor's degree in BiologyBachelor's degree in BiochemistryBachelor's degree in MicrobiologyBachelor's degree in Chemistry