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Regulatory Affairs Specialist – Registration
Aché Laboratórios. Assess the regulatory feasibility of innovation, development, and new registration projects, defining strategies aligned with the current regulatory framework and the company’s objectives .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Regulatory Affairs with a strong focus on ANVISA regulations, drug registration processes, and innovative regulatory strategies. Capable of leading complex projects and providing specialized support throughout the product life cycle while ensuring compliance with national and international regulations.
Highest-signal resume keywords
Regulatory Affairs ExperienceANVISA Regulations KnowledgeRegulatory Strategy DevelopmentDrug Registration Dossier PreparationAdvanced English Proficiency
ATS Keywords
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Hard Skills
Regulatory Feasibility AssessmentDrug Registration ApplicationsProject LeadershipRegulatory ComplianceTechnical Documentation Review
Soft Skills
Strategic PartnershipKnowledge SharingRisk IdentificationOpportunity Analysis
Industry Keywords
Pharmaceutical IndustryInnovation ProjectsHealth AuthoritiesProduct Life CycleCosmeticsFoodMedical Devices
About the role
Key responsibilities & impact- Assess the regulatory feasibility of innovation, development, and new registration projects, defining strategies aligned with the current regulatory framework and the company’s objectives
- Act as a strategic partner to R&D, Innovation, Pharmaceutical Development, Quality, Supply, and Business teams
- Lead regulatory discussions for highly complex projects, identifying risks, opportunities, and requirements
- Prepare, review, submit, and track drug registration applications with ANVISA and other health authorities
- Develop innovative regulatory strategies to accelerate approvals and support new development models
- Interpret and monitor national and international legislation, regulations, and regulatory trends
- Represent Regulatory Affairs on committees, in strategic meetings, and in interactions with authorities, partners, and industry associations
- Provide specialized technical and regulatory support throughout the product life cycle
- Serve as a technical reference for complex registration, development, and innovation matters, promoting knowledge sharing and best practices
Requirements
What you’ll need- Bachelor’s degree in Pharmacy
- Strong experience in Regulatory Affairs within the pharmaceutical industry
- Advanced knowledge of ANVISA regulations applicable to drug registration and innovation
- Experience developing regulatory strategies and leading highly complex projects
- Experience assessing the regulatory feasibility of new products, technologies, partnerships, and innovation projects
- Experience preparing and submitting drug registration dossiers
- Intermediate to advanced English proficiency for interaction with global partners and review of technical documentation
- Experience with cosmetics, food, and medical devices is a plus
- Intermediate to advanced Spanish proficiency is a plus
Benefits
Comp & perks- Medical and dental insurance
- Aché and Biosintética medications provided at no cost to you and your eligible dependents
- Preventive examinations with no copay
- On-site medical consultations and diagnostic test collection*
- Wellhub (formerly Gympass)
- “Estar Bem Aché” integrated health program
- Support programs for pregnant and postpartum employees and spouses
- Partnerships and agreements offering educational scholarships and discounts
- Profit-Sharing Program (PPR)
- Private pension plan (1:1 employer match)
- On-site restaurant and meal allowance
- Transportation allowance, parking, or company shuttle service*
- Childcare allowance or exclusive daycare center at the Guarulhos site
- Exclusive Short Friday program at the Guarulhos site for administrative positions
- Christmas gift