Regulatory Affairs Consultant

A Consultant must have an understanding of the organization’s consulting models and methodologies, as well as, good knowledge of what services Parexel 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 timely performance of work within a project scope to the quality expectations of Parexel and the client. When serving as a Global Regulatory Lead or Regional Regulatory Lead, a Consultant assures the work of the entire team is delivered on time and that it meets client’s and Parexel’s quality expectations. As a Consultant you will have the opportunity to work within Regulatory Authority Submissions related to Clinical Trials, supporting many projects in Brazil and acting as Global Regulatory Lead/Regional Regulatory Lead 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 point of contact for the study team regarding Regulatory Authority Submissions. • Provide 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 quality control of documents; • Provide advice and guidance to internal and external 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 within 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 within a team environment but may work independently delivering services within their technical area of expertise • Works within 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 achieve specified project outcomes • Capitalizes on opportunities to improve one’s own performance and may provide suggestions for improving project efficiencies and results to the project lead • Seeks out information from previous projects, other client work or from colleagues to complete assigned project activities • Produces quality work that meets the expectations of Project Lead and the client • May serve as a Global Regulatory Lead or Regional Regulatory Lead • Ensures that appropriate risk identification and issue-escalation procedures are in place • Identifies new opportunities through Change In Scope or add-on business from existing work • Ensures timely project close-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 within personal area of expertise • Completes assigned activities within project scope and objectives with an understanding of issues which may impact project profitability • Collaborates with colleagues and client 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 methods of executing project activities • Proactively assesses client 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 Parexel 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 Parexel management and account managers • May participate in project scoping calls and/or proposal preparation with the support of senior colleagues Parexel-Related Activities • Meets established metrics as specified in scorecard on an annual basis • Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of arenaflex, training compliance, project deliverable archiving, participation in internal initiatives/projects or as a mentor as requested by management • Defines self-development activities in order to keep current within the industry (i.e. maintain membership in a relevant industry and/or scientific/technical association) Skills: • Project management knowledge • Client-focused 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-related environment Education: • Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred #LI-REMOTE Apply tot his job Apply tot his job