I contribute to clinical research with expertise and empathy. And I do it
Regulatory Affairs Consultant
Primary Location: Brazil, Remote Job ID R0000036226 Category Regulatory Affairs Date Posted 12/10/2025Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
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
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