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 CVs, 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