Regulatory and Quality Affairs Pharmacist

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🕒 May 15

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Participates in regulatory affairs activities, including preparation, submission, and maintenance of dossiers for pharmaceutical products, with emphasis on biological products. • Ensures compliance with national and international pharmaceutical regulations, including ANVISA requirements and global guidelines. • Acts as the primary contact for regulatory authorities and certification bodies. • Oversees quality assurance processes, including audits, inspections, and corrective/preventive actions. • Develops, implements, and monitors Standard Operating Procedures (SOPs). • Collaborates with cross-functional teams to ensure product quality and regulatory compliance. • Supports continuous improvement initiatives in quality systems. • Provides senior review of regulatory documents and submissions created within or outside of the company to ensure high-quality standards that meet or exceed client expectations and local/regional requirements. • Serves as a subject matter expert, providing regulatory strategy advice to internal and external clients on projects of moderate complexity. • Provides internal clients with up-to-date legislation and guidance as it becomes available. • Participates in project management activities to support the provision of regulatory services and acts as liaison with internal and external clients in marketing these services. • Provides matrix/project leadership, training, and guidance to junior team members to support understanding of regulations, impact on studies, risk assessment, and to achieve project goals and deliverables. • May provide input on performance reviews to management. • Ensures adherence to project budgets, schedules, and scope of work. • Ensures compliance with relevant organizational and regulatory SOPs and WPDs. • Contributes to business development activities, including project budgeting and forecasting.

🎯 Requirements

• Degree in Pharmacy (mandatory) • Active CRF registration (mandatory) • Minimum of 5 years of experience in the pharmaceutical industry, specifically in Regulatory Affairs and Quality Assurance • Proven experience with biological products • Strong knowledge of Brazilian pharmaceutical regulations • Excellent English (written and oral) and local language (where applicable) communication skills • High attention to detail and quality, with excellent editorial/proofreading skills • Strong interpersonal skills to work effectively in a team environment and liaise with other departments • Strong computer skills, including Microsoft Office (Word, Excel, PowerPoint, Outlook); ability to learn new technologies • Solid organizational, time management, and planning skills to create and maintain timelines, conduct long-range planning, adapt to changing priorities, and manage multiple projects • Strong negotiation skills • Able to work independently and exercise judgment to assess sponsor regulatory needs and collaborate with project team members to produce compliant deliverables • Strong 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 regulatory specialty areas such as preclinical, clinical, CMC, and publishing • Strong understanding of medical terminology, statistical concepts, and related guidelines • Excellent analytical, investigative, and problem-solving skills • Solid understanding of budgeting and forecasting

🏖️ Benefits

• Health insurance • Professional development opportunities