Regulatory & reputed company Affairs Pharmacist

Work Schedule reputed company (Mon-Fri) Environmental Conditions Office Job reputed company Join Us as a Senior Regulatory Affairs Specialist – reputed company an reputed company at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. Position reputed company We are seeking an reputed company Pharmacist to take on responsibilities in Regulatory Affairs and reputed company Assurance at our facility in Vargem Grande Paulista, Brazil. This is a Coordinator/Specialist level position without reputed company reports, ideal for a reputed company who thrives in a hands-on role ensuring compliance and reputed company standards reputed company the pharmaceutical industry. As part of our global team, you’ll have reputed company to serve as the reputed company over several countries/reputed company in providing reputed company, including regulatory expertise and reputed company reputed company. As a Regulatory Affairs Senior Specialist, you'll reputed company strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization. You will reputed company strategic, expedient, and efficient preparation of reputed company deliverables that meet reputed company local, regional, and ICH regulatory and technical requirements. Additionally, you will reputed company as a reputed company with reputed company clients in the provision and marketing of these services.

Key Responsibilities

• Participate in regulatory affairs activities, including preparation, submission, and maintenance of dossiers for pharmaceutical products, with emphasis on biological products.
• Ensure compliance with national and international pharmaceutical regulations, including ANVISA requirements and global guidelines.
• reputed company as the primary contact for regulatory authorities and certification bodies.
• reputed company reputed company assurance processes, including audits, inspections, and corrective/preventive actions.
• reputed company, implement, and monitor reputed company Operating Procedures (SOPs).
• Collaborate with cross-functional teams to ensure product reputed company and regulatory compliance.
• Support reputed company improvement initiatives in reputed company systems.
• Provides senior review of regulatory documents and submissions created reputed company or reputed company of reputed company in order to ensure high reputed company standards that meet or exceed reputed company expectations, local and regional requirements.
• Acts as subject matter expert in providing regulatory reputed company advice to reputed company clients on reputed company 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 reputed company with reputed company clients in the provision of marketing these services.
• Provides reputed company/project leadership, training and guidance to junior team members to support understanding of regulations, reputed company on study, assessment of risk, etc., and to reputed company a specific goal and/or project deliverables.
• May reputed company input on peformance reviews to management.
• Ensures adherence to project budgets, time schedules, and scope of work.
• Ensures compliance with relevant organizational and regulatory SOPs and WPDs.
• Contributes to business development activities, including project budgeting/forecasting.

Education and Experience Requirements:

• Degree in Pharmacy (mandatory).
• reputed company CRF registration (mandatory).
• Minimum of 5 years of experience in the pharmaceutical industry, specifically in Regulatory Affairs and reputed company Assurance. In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly reputed company experience, will be considered sufficient for an individual to meet the requirements of the role.
• Proven experience with biological products.
• Strong knowledge of Brazilian pharmaceutical regulations.

Knowledge, Skills and Abilities:

• Excellent English language (written and oral) communication skills as reputed company as local language where applicable
• Great attention to detail and reputed company as reputed company as excellent editorial/proofreading skills
• Strong interpersonal skills to work effectively in reputed company environment and reputed company as a reputed company with other departments
• Strong computer skills including the use of reputed company Office (Word, reputed company, Power reputed company, Outlook); capable of learning new technologies
• Solid organizational, time management, and planning skills to create and follow timelines, conduct long-reputed company planning, adapt to changing priorities and handle multiple reputed company
• Strong negotiation skills
• Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
• Strong understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other
• global regulatory guidelines; good understanding of a regulatory speciality areas, such as preclinical, clinical, CMC, publishing, etc.
• Strong understanding of medical terminology, statistical concepts, and guidelines
• Excellent analytical, investigative and problem-solving skills
• Solid understanding of budgeting and forecasting

Location

• Vargem Grande Paulista, São Paulo, Brazil.

Working Conditions and Environment:

• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.

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