Senior Regulatory Affairs Analyst

Jobtailor; Pinhais; Presencial; BRL 90 000 - 130 000; Tempo integral

Resumo da oferta

Jobtailor in Brazil seeks a Regulatory Affairs professional to prepare and renew product notifications and registrations with ANVISA. You will assess regulatory requirements, update technical files, and coordinate with R&D to embed regulatory needs from concept to market.

The role requires a proactive, organized individual with strong communication and analytical skills, familiar with healthcare regulations and product labeling compliance.

Qualificações

• Demonstrates expertise in regulatory documentation preparation for product notification and registration with ANVISA and other regulators.
• Ability to assess regulatory risks and maintain up‑to‑date technical files and product master records.
• Intermediate to advanced English proficiency required.

Responsabilidades

• Prepare, analyze, and renew regulatory documentation for product notification and registration with ANVISA and other regulators.
• Assess regulatory requirements and risks for new products or changes.
• Prepare and review dossiers for notifications, registrations, and renewals.
• Respond to agency requirements and amend registrations as needed.
• Monitor registration processes and ensure compliance with regulations.

Conhecimentos

Regulatory documentation

Dossier preparation

English proficiency

Communication skills

Analytical ability

Formação académica

Bachelor's Degree in Pharmacy

Bachelor's Degree in Biology

Bachelor's Degree in Biomedicine

Descrição da oferta de emprego

• Prepare, analyze, and renew companies' legal documentation for product notification and registration with ANVISA and other regulatory bodies, including medium- and high-complexity submissions
• Understand current regulatory requirements related to product notification, registration, and health-risk classification
• Assess regulatory risks associated with new products, process changes, or expansion into new markets
• Prepare and review dossiers for low- and medium-complexity notifications, registrations, post-registration changes, and renewals
• Respond to requirements issued by regulatory agencies
• Amend product notifications and registrations with regulatory authorities
• Monitor registration processes for new products, post-registration changes, and renewals
• Evaluate marketing materials and review product copy and labeling in accordance with current regulations
• Review the Official Gazette of the Federal Government, state, and municipality to verify product registration approvals and legislation related to medical devices and healthcare products
• Update and maintain supplier documentation appropriate to each business
• Translate documents and technical materials within established deadlines
• Keep product technical files up to date and compliant with regulatory requirements
• Keep the Product Master Record (RMP) up to date
• Stay current on applicable regulations and changes affecting the group's companies
• Advise clients and employees from other departments on healthcare and regulatory requirements
• Support the department manager on matters related to the area
• Participate in meetings with regulatory agencies and provide support during inspections and audits
• Conduct internal audits, identify and correct nonconformities, and implement corrective and preventive actions
• Collaborate with R&D teams to ensure regulatory requirements are incorporated from the new-product development stage
• Draft letters, declarations, and guidance materials related to regulations and internal procedures

Requirements

• Bachelor's degree in Pharmacy, Biology, Biomedicine, or a related field
• Extension course in healthcare regulatory affairs
• Intermediate to advanced English proficiency
• Proactive, organized, and adaptable to regulatory changes
• Strong communication and interpersonal skills
• Initiative and analytical ability

Core Competencies

Demonstrates expertise in regulatory documentation preparation, analysis, and compliance for product notification and registration with ANVISA and other regulatory bodies. Proficient in assessing regulatory risks and maintaining up-to-date technical files and product master records.

Highest-signal resume keywords

• Regulatory Documentation Preparation
• Regulatory Risk Assessment
• Product Notification and Registration
• Intermediate to Advanced English Proficiency
• Healthcare Regulatory Affairs Certification

Hard Skills

• Regulatory Requirements Analysis
• Dossier Preparation
• Product Labeling Review
• Internal Audits
• Technical File Maintenance

Soft Skills

• Strong Communication Skills
• Interpersonal Skills
• Proactive Attitude
• Organizational Skills
• Analytical Ability

Certifications & Qualifications

• Bachelor's Degree in Pharmacy
• Bachelor's Degree in Biology
• Bachelor's Degree in Biomedicine
• Extension Course in Healthcare Regulatory Affairs

Industry Keywords

• ANVISA
• Medical Devices
• Healthcare Products
• Regulatory Agencies
• Product Master Record