Regulatory and Quality Affairs Pharmacist

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Engages in regulatory affairs functions, which include the preparation, submission, and maintenance of dossiers for pharmaceutical products, particularly focusing on biological products.

• Ensures adherence to both national and international pharmaceutical regulations, encompassing ANVISA requirements and global standards.

• Serves as the main point of contact for regulatory authorities and certification organizations.

• Manages quality assurance processes, including conducting audits, inspections, and implementing corrective/preventive actions.

• Creates, executes, and monitors Standard Operating Procedures (SOPs).

• Works collaboratively with cross-functional teams to guarantee product quality and compliance with regulations.

• Aids in continuous improvement initiatives within quality systems.

• Conducts senior-level reviews of regulatory documents and submissions generated internally or externally to ensure they meet or exceed client expectations and local/regional standards.

• Acts as a subject matter expert, offering regulatory strategy advice to both internal and external clients on projects of moderate complexity.

• Keeps internal clients informed about the latest legislation and guidance as it becomes available.

• Participates in project management tasks to facilitate the delivery of regulatory services and serves as a liaison with internal and external clients to promote these services.

• Provides matrix/project leadership, training, and mentorship to junior team members, helping them understand regulations, assess risks, and achieve project objectives and outcomes.

• May contribute insights to performance reviews for management.

• Ensures compliance with project budgets, timelines, and scopes of work.

• Adheres to relevant organizational and regulatory SOPs and WPDs.

• Participates in business development activities, including project budgeting and forecasting.

⛳️ Requirements

• Bachelor's degree in Pharmacy (mandatory).

• Active CRF registration (mandatory).

• At least 5 years of experience in the pharmaceutical sector, specifically in Regulatory Affairs and Quality Assurance.

• Demonstrated experience with biological products.

• In-depth knowledge of Brazilian pharmaceutical regulations.

• Proficient in English (both written and oral) and local language (where applicable) communication skills.

• Exceptional attention to detail and quality, along with strong editorial/proofreading capabilities.

• Excellent interpersonal skills, enabling effective teamwork and collaboration with other departments.

• Strong computer proficiency, including Microsoft Office Suite (Word, Excel, PowerPoint, Outlook); ability to adapt to new technologies.

• Solid organizational, time management, and planning abilities to create and maintain timelines, conduct long-term planning, adapt to shifting priorities, and manage multiple projects.

• Proficient negotiation skills.

• Capable of working independently and making informed judgments to assess sponsor regulatory needs while collaborating with project team members to produce compliant deliverables.

• Comprehensive understanding of global, regional, and national regulatory requirements/procedures for clinical trial authorization, licensing, and lifecycle management; expert knowledge of ICH and other global regulatory guidelines; good understanding of specialized regulatory areas such as preclinical, clinical, CMC, and publishing.

• Strong grasp of medical terminology, statistical concepts, and associated guidelines.

• Excellent analytical, investigative, and problem-solving abilities.

• Solid understanding of budgeting and forecasting.

🏝️ Benefits

• Health insurance.

• Professional development opportunities.