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Regulatory Affairs Analyst – Start-Up
Location
Brazil
Posted
5 days ago
Salary
0
Seniority
Senior
Job Description
Regulatory Affairs Analyst – Start-Up
SYNVIA
• Handle sponsors' requests with the required level of detail and grounding in current legislation; • Participate in discussions to define the optimal strategy for different projects; • Identify potential risks and opportunities for projects arising from changes in legislation and/or applicable requirements; • Participate in discussions to select the best strategy for different projects (clinical research and products); • Perform technical review of documents prior to regulatory submission; • Prepare and review documents, including assembling clinical research dossiers and dossiers for different product categories for submission to ANVISA; • Conduct critical analysis of technical dossiers for registration and post-registration purposes in Brazil; • Assist in the design and discussion of the clinical development plan for an investigational product; • Revise and adapt prepared documents, when necessary, following review by project stakeholders; • Contribute technical responses to requirements issued by competent authorities; • File project documents according to internal procedures; • Keep the project database updated according to internal procedures; • Review Standard Operating Procedures relevant to the department; • Monitor publications of interest to the company and/or sponsors in the Official Federal Gazette (Diário Oficial da União); • Participate in Regulatory and Scientific Affairs team meetings and whenever requested; • Attend technical meetings with sponsors and regulatory authorities together with the Regulatory Affairs and Start-Up Management, when necessary; • Keep up to date with regulations and technical requirements applicable to the Brazilian regulatory agency and international guidelines for planning, conduct and submission of projects; • Participate in specific technical working groups of external entities when the topic has significant impact for the company and/or sponsors.
Job Requirements
- Bachelor's degree in Pharmacy;
- Advantage: postgraduate degree in Regulatory Affairs, Health Surveillance or related area;
- Previous experience in Regulatory Affairs, preferably in the pharmaceutical industry, a CRO or consultancy;
- Experience with submissions and protocols to ANVISA;
- Knowledge of Brazilian sanitary legislation (ANVISA): RDCs on registration, post-registration, bioequivalence/bioavailability studies, clinical research, good practices (GMP/GCP), pharmacovigilance;
- Desirable: knowledge of international standards, e.g., FDA and ICH;
- Technical and scientific writing skills (clarity and precision);
- Organized, detail-oriented and able to meet deadlines;
- Advanced MS Office (Word, Excel, PowerPoint);
- Advantage: familiarity with Artificial Intelligence tools applied to drafting, review and verification of regulatory documents, with ability to critically validate generated results;
- Analytical skills and critical review of documents;
- Teamwork and effective communication with internal areas and regulatory authorities;
- Advanced English;
- Intermediate Spanish.
Benefits
- Commuter allowance (Vale Transporte);
- Parking (subject to availability);
- Health plan with no monthly cost to the employee; copay for tests and consultations;
- Dental plan with employee copay;
- Life insurance at no cost to the employee;
- Flexible meal/food allowance;
- Pharmacy discount program;
- Flexible time bank — holidays and commemorative dates (per internal policy);
- SESC partnership;
- Physical health program - TotalPass;
- Day Off — Health Professional;
- Childcare allowance (per internal policy).
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