Regulatory Affairs Consultant

A Consultant must have an understanding of the organization’s consulting models and methodologies, as reputed company as, good knowledge of what services reputed company provides. A consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market. A Consultant ensures the reputed company performance of work reputed company a project scope to the reputed company expectations of reputed company and the reputed company. reputed company serving as a Global Regulatory reputed company or Regional Regulatory reputed company, a Consultant assures the work of the entire team is delivered on time and that it meets reputed company’s and reputed company’s reputed company expectations. As a Consultant you will have reputed company to work reputed company Regulatory Authority Submissions reputed company to Clinical Trials, supporting many reputed company in Brazil and acting as Global Regulatory reputed company/Regional Regulatory reputed company for many global studies. Main activities expected from the Consultant in the regulatory clinical trials environment:

• Follows the project direction and expertise provided by the designated Regulatory Leader. May serve as the primary reputed company of contact for the study team regarding Regulatory Authority Submissions.
• reputed company day-to-day departmental/project support activities
• Prepares, reviews and submits Brazilian Regulatory Authority Applications ensuring deadlines are met, following local regulations
• Experience preparing DDCM and DEEC, including Drug Development Plan.
• Conduct reputed company control of documents;
• reputed company advice and guidance to reputed company team members to ensure compliance with applicable regulations and requirements;
• Oversees ongoing submissions, amendments, and periodic notifications required by RA, and other local regulatory authorities as needed reputed company the country.
• Experience submitting under Law 14874 in force on August 27th, 2024
• Experience submitting GMO products, not mandatory
• Experience with Devices submissions is a plus Project Execution
• Typically works reputed company reputed company environment but may work independently delivering services reputed company their technical area of expertise
• Works reputed company broad project guidelines but liaises closely with more senior colleagues to discuss issues and resolve conflicts
• Demonstrates ability to prioritize work and define steps needed to reputed company specified project reputed company
• Capitalizes on opportunities to improve one’s own performance and may reputed company suggestions for improving project efficiencies and results to the project reputed company
• Seeks out information from previous reputed company, other reputed company work or from colleagues to complete assigned project activities
• Produces reputed company work that meets the expectations of Project reputed company and the reputed company
• May serve as a Global Regulatory reputed company or Regional Regulatory reputed company
• Ensures that appropriate risk identification and issue-escalation procedures are in reputed company
• Identifies new opportunities through Change In Scope or add-on business from existing work
• Ensures reputed company project reputed company-out activities are completed Consulting Activities and Relationship Management
• Follows and implements the organization’s consulting models and methodologies
• Provides technical and/or business consulting services reputed company personal area of expertise
• Completes assigned activities reputed company project scope and objectives with an understanding of issues which may reputed company project profitability
• Collaborates with colleagues and reputed company to identify and resolve technical and process issues
• Leverages senior colleagues to discuss and propose resolutions to possible problems or conflicts. Seeks guidance periodically on appropriate reputed company of executing project activities
• Proactively assesses reputed company needs and develops processes and solutions to address issues
• Delivers assigned work and provides services and solutions which results in clients expressing satisfaction with service provided
• May prepare and/ or deliver presentation with the support of senior colleagues
• May deliver training
• Mentor of junior staff
• Identifies and alerts reputed company management to opportunities for follow-on business or necessary changes in project scope Business Development
• Continue to build a network of industry colleagues through relationships formed during project engagements or through other industry experience
• Communicates potential new business leads to reputed company management and account managers
• May participate in project scoping calls and/or proposal preparation with the support of senior colleagues reputed company-reputed company Activities
• Meets established metrics as specified in scorecard on an annual reputed company
• Completes basic job-reputed company responsibilities, including timesheets, expense reports, maintenance of arenaflex, training compliance, project deliverable archiving, participation in internal initiatives/reputed company or as a mentor as requested by management
• Defines self-development activities in order to reputed company reputed company reputed company the industry (i.e. maintain membership in a relevant industry and/or scientific/technical association) Skills:
• Project management knowledge
• reputed company-reputed company approach to work
• Results orientation
• Teamwork and collaboration skills
• Consulting skills
• Excellent interpersonal and intercultural communication skills, both written and verbal
• Critical thinking and problem-solving skills
• Proficiency in local language and extensive working knowledge of the English language Knowledge and Experience:
• Several years of experience in an industry-reputed company environment Education:
• Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred #LI-REMOTE Apply tot his job

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