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Regulatory Affairs Consultant - Regulatory Strategist

Primary Location: Mexico, Remote Additional Locations: Argentina, Remote Job ID R0000046450 Category Regulatory / Consulting Date Posted 10/01/2026

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- Success profile

- About this role

- Employee insights

- Why Consultants work at Parexel

- Learn about our culture

Overview

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

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About This Role

Consultant of Regulatory Strategy

About Parexel

Parexel is a leading Clinical Research Organization (CRO) and biopharmaceutical consulting company dedicated to advancing patient care through innovative clinical trials, regulatory expertise, and strategic consulting services. With a global presence and deep industry expertise, Parexel partners with biopharmaceutical companies, medical device manufacturers, and government agencies to bring life-changing therapies to patients worldwide. Our mission centers on patient focus, quality and integrity, respect and teamwork, and innovation—values that guide everything we do.

Position Overview

This role provides comprehensive regulatory support for programs within the Infectious Diseases franchise. Based in Mexico with in-office work requirements, the successful candidate will manage regulatory dossiers, guide registration applications, and serve as a key liaison with LATAM Health Authorities.

Key Responsibilities

Regulatory Strategy &

- Development

- Partner with general regulatory leads,



regulatory strategists, Global Regulatory Sub-Teams, and project teams to develop and execute regulatory strategy throughout the product development lifecycle

- Identify and assess regulatory risks for assigned projects or programs

- Serve as point of contact with regulatory agencies relevant to assigned projects or programs, as appropriate

Regulatory Submissions &

- Documentation

- Coordinate, develop, and contribute to the content and format of regulatory submissions and related supplements and amendments

- Manage submissions including:

- FDA meeting requests and briefing books

- INDs (Investigational New Drug applications)

- CTAs (Clinical Trial Applications)

- Pediatric plans

- DSURs (Periodic Safety Update Reports)

- MAA/BLA/NDA (Marketing Authorization Applications, Biologics License Applications, New Drug Applications)

- Orphan drug designations

- Other regulatory submissions as needed

Administrative &

- Compliance

- Track, follow up, and archive correspondence with Health Agencies

- Monitor and document regulatory commitments and queries from Health Authorities

- Maintain accurate regulatory records and documentation

Collaboration &

- Project Management

- Work both independently and within project teams, committees, and cross-functional groups to achieve organizational goals

- Demonstrate strong organizational skills and ability to prioritize workload effectively

Required Qualifications

- Education: BA/BS degree in a scientific, engineering, or healthcare discipline (Masters, PharmD, or PhD preferred)

- Experience: 5 years in the pharmaceutical industry, preferably with LATAM country experience

- Regulatory Expertise: 3 years of regulatory strategy experience or relevant equivalent training/experience

- Technical Knowledge

Strong knowledge of current US and EU regulations

Strong experience with CTD (Common Technical Document) format and content

- Comprehensive knowledge of regulatory procedures and legislation for drug development, product registration, line extensions, and license maintenance (preferably from both US and EU markets)

- Understanding of clinical and pre-clinical regulatory aspects of product development

- Experience authoring regulatory documents

Preferred Qualifications

- Experience in Infectious Diseases and/or Biologicals

- Demonstrated expertise in preparing regulatory submissions and supportive amendments or supplements

- Knowledge of applicable regulations across multiple jurisdictions

Required Competencies





- Communication: Exceptional written and oral communication skills in both English and Spanish

- Organization: Strong organizational abilities with proven capacity to manage multiple priorities

- Independence &
- Collaboration: Ability to work autonomously while effectively contributing to team objectives

- Attention to Detail: Meticulous approach to regulatory documentation and compliance

This position offers an opportunity to play a critical role in bringing infectious disease treatments to market across Latin America while working with a global regulatory team.

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Employee Insights

How to describe Parexel culture in one word

Insights from Parexel employees

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Jo on diverse project work and team culture

Jo Wang | Vice President, Technical

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Kurt on colleagues and growth opportunities

Kurt Brorson | Vice President, Technical

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Why Consultants work at Parexel

Patient-led in everything we do

We are inspired by the patients behind the data and therefore deliver first-time quality and on-time projects.

Supportive and inclusive environment

We thrive on collaboration, caring, and inclusivity - enabling our people to work together to solve complex problems and share knowledge.

Opportunities for career growth

We provide a wide range of challenging assignments, product types, geographic regions, and therapeutic areas, providing ample opportunities for learning and growth.

Flexible work arrangements

We offer the flexibility of remote work, allowing you to balance your personal and professional responsibilities while still contributing to our “We Care” team environment.

Diverse and global client exposure

We continuously learn by working with a global network of colleagues and clients to develop regulatory strategies to support their product development and approval.

Learn from experts

You will work with a team of highly experienced regulatory professionals who can serve as mentors, providing guidance and support as you develop your skills and advance in your career.

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Learn About Our Culture

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- Inclusion at Parexel

Learn how Parexel celebrates the differences our workforce and patients bring and ensures an inclusive environment.

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- Benefits &
- Support

At Parexel, we prioritize putting people first, allowing you to achieve your best work. Explore the Flexible Work Program, our "Bravo" Recognition Program, and how we build our well-being in our supportive culture.

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- Emerging Talent Opportunities

Begin your career journey at Parexel with our emerging talent programs or our internships, placements and entry-level clinical roles. Advance science by keeping the patients in mind.

Learn More

📌 Regulatory Affairs Consultant - Regulatory Strategist (Ciudad de México)
🏢 ATLAS MEDICAL SERVICES LTD. STI.
📍 Ciudad de México