Sr. Associate, Regulatory Strategy

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

About This Role

Work location and arrangement: Mexico City - Hybrid

We are seeking a Sr. Associate, Regulatory Strategy with strong experience in regulatory affairs, dossier management, registration applications, and interactions with LATAM Health Authorities.

In this role, you will provide comprehensive regulatory support to the Director, Regulatory Affairs & Quality Assurance, with a focus on COFEPRIS interactions and product lifecycle management.

About the Role

This position offers the opportunity to drive regulatory strategy and execution for product programs in the LATAM region. You will work independently on assigned deliverables while collaborating closely with global and regional

partners to ensure timely, compliant submissions and approvals.

Key Responsibilities

• Regulatory Strategy & Planning

• Support the Director, Regulatory Affairs & Quality Assurance in the execution of regulatory strategies and priorities for product lifecycle

• Perform initial regulatory impact assessments for proposed global changes and provide recommendations on submission requirements, sequencing, dependencies, documentation needs, and anticipated timelines

• Identify and assess regulatory risks, issues, dependencies, and potential delays for assigned activities, and escalate them to the Director with proposed mitigation actions

• Monitor regulatory requirements, COFEPRIS criteria, procedural updates, and emerging practices; provide concise regulatory intelligence and impact assessments

• Submissions & Authority Management

• Demonstrate hands-on experience supporting regulatory procedures before COFEPRIS, including preparation and follow-up submissions, responses to queries, commitments, and post-approval activities

• Coordinate labeling and artwork regulatory activities, including review of local prescribing information and packaging components, alignment with approved conditions, and implementation of safety-related updates

• Maintain an integrated regulatory portfolio view, including registrations, submissions, approvals, commitments, renewals, post-approval changes, authority requests, key dependencies, and upcoming milestones

• Maintain accurate regulatory plans, submission schedules, trackers, and status reports; provide clear operational updates to the Director and relevant stakeholders

• Own assigned regulatory activities end-to-end, proactively driving inputs, timelines, document readiness, follow-up, and closure

• CMC & Post-Approval Changes

• Coordinate regulatory assessments and execution of CMC and manufacturing-related changes, including manufacturing sites, specifications, processes, analytical methods, packaging, and other post-approval changes

• Collaborate closely with Global Regulatory CMC, Quality, and Supply Chain teams to ensure alignment and timely execution

• Documentation & Compliance

• Ensure regulatory records, submissions, approvals, correspondence, and commitments are appropriately documented and maintained in applicable Moderna regulatory systems and repositories

• Support the Director in the execution and follow-up of local Quality activities, priorities, and compliance requirements

• Support the management, documentation, and follow-up of quality events, including deviations, CAPAs, change controls, complaints, and other quality-related actions

• Support inspection and audit readiness activities, including preparation and organization of documentation, tracking of requests and observations, and follow-up of agreed actions

• Cross-Functional Collaboration

• Coordinate with Global Regulatory, Regional Regulatory, Medical, Pharmacovigilance, Supply Chain, Quality, Commercial, and other cross-functional partners to obtain inputs and maintain delivery timelines

• Escalate strategic decisions, material risks, and authority-sensitive matters to the Director as appropriate

Required Qualifications

• BA/BS degree in a scientific, engineering, or healthcare discipline
• 5+ years of experience in the pharmaceutical industry, preferably in LATAM countries
• 3+ years of experience in regulatory strategy or relevant training/experience
• Exceptional written and oral communication in English and Spanish
• Strong knowledge of current US and EU regulations
• Strong experience with CTD format and content of regulatory filings
• Knowledge and broad experience with regulatory procedures and legislation for drug development, product registration, line extension, and license maintenance
• Demonstrated strong organizational skills, including the ability to prioritize workload
• Experience in the preparation of regulatory submissions and supportive amendments or supplements
• Experience authoring regulatory documents
• Knowledge and understanding of applicable regulations

Preferred Qualifications

• Masters, PharmD, or PhD degree
• Experience in Infectious Diseases and Biologicals
• Experience working on products in development, specifically relating to clinical and pre-clinical regulatory aspects
• Experience with regulatory procedures and legislation from both US and EU markets

Parexel is a leading clinical research organization (CRO) providing comprehensive drug development and commercialization services to the pharmaceutical and biotech industries. We partner with innovative companies to bring life-changing therapies to patients worldwide. This position is being filled through our recruitment partnership services.

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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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