Regulatory Affairs Consultant - Regulatory Strategist

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 global 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.