Regulatory Affairs Analyst – Start-Up

Job not on LinkedIn

🔥 0 minutes ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

SYNVIA

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1993

🚗 Transport

🤝 B2B

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

• 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.

🎯 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).