Regulatory Affairs Analyst – Start-Up

Job not on LinkedIn

🔥 14 hours ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 19%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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SYNVIA

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1993

📦 Logistics

🚗 Transport

🤝 B2B

Logistics • Transport • B2B

SYNVIA is a logistics and transport company specializing in secure, compliant, and customized supply chain solutions for high‑value and sensitive industries. The company provides multimodal transport (road, air, maritime), temperature‑controlled and regulated warehousing (including ICPE), handling of dangerous goods, customs transit services, and value‑added operations like co‑packing, labeling and kitting. SYNVIA focuses on B2B clients in sectors such as chemistry, energy, agriculture, cosmetics and public hygiene, emphasizing traceability, regulatory compliance, and operational agility.

📋 Description

• Address sponsor requests with the required level of detail and support them with the applicable current legislation • Participate in discussions to define the best strategy for different projects • Identify potential risks and opportunities for projects when applicable legislation and/or requirements change • Participate in discussions to select the best strategy for different projects involving clinical research and products • Technically review documents before regulatory submission • Prepare and review documents, including compiling clinical research dossiers and dossiers for different product categories for submission to ANVISA • Conduct critical reviews of technical dossiers for product registration and post-registration purposes in Brazil • Assist in defining and discussing the clinical development plan for an investigational product • Revise prepared documents as necessary following review by the parties involved in the project • Contribute to technical responses to requirements issued by the competent authorities • File research project documents in accordance with internal procedures • Keep the project database up to date in accordance with internal procedures • Review Standard Operating Procedures (SOPs) relevant to the department • Monitor publications of interest to the company and/or sponsors in the Official Gazette of the Union • Participate in Regulatory and Scientific Affairs meetings and other meetings whenever requested • Participate in technical meetings with sponsors and regulatory authorities alongside the Regulatory Affairs and Start-Up Management team, when necessary • Stay current with regulations and applicable technical requirements established by the Brazilian regulatory agency, as well as international guidelines for project planning, conduct, and submission • Participate in specific technical groups of organizations when the topic has a significant impact on the company and/or sponsors

🎯 Requirements

• Bachelor’s degree in Pharmacy • Preferred: postgraduate degree in Regulatory Affairs, Health Surveillance, or a related field • Previous experience in Regulatory Affairs, preferably in the pharmaceutical industry, a CRO, or consulting • Experience with submissions and protocols to ANVISA • Knowledge of Brazilian health regulations (ANVISA), including RDCs governing registration, post-registration, bioequivalence/bioavailability studies, clinical research, Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and pharmacovigilance • Knowledge of international regulations and guidelines, such as FDA and ICH, is preferred • Strong technical and scientific writing skills, with clarity and precision • Excellent organizational skills, attention to detail, and ability to meet deadlines • Advanced proficiency in Microsoft Office (Word, Excel, and PowerPoint) • Preferred: Familiarity with AI tools applied to the drafting, review, and verification of regulatory documents, with the ability to critically validate generated results • Analytical skills and a critical approach to document review • Ability to work as part of a team and communicate with internal departments and regulatory authorities • Advanced English proficiency • Intermediate Spanish proficiency

🏖️ Benefits

• Transportation allowance • Parking (subject to availability) • Health insurance with no monthly premium for employees; co-payments apply to examinations and consultations • Dental insurance with a monthly premium co-payment • Life insurance at no cost to employees • Flexible meal and food allowance • Pharmacy benefit program • Flexible time bank for holidays and commemorative dates (in accordance with internal policy) • SESC partnership • Physical wellness program – TotalPass • Day off for healthcare professionals • Childcare assistance (in accordance with internal policy)