Consultant, Regulatory Affairs and Quality

Consultant, Regulatory Affairs and Quality – Mexico (FSP)

Position Overview

We are seeking a Consultant, Regulatory Affairs in Mexico, to provide primarily operational regulatory support to the Director, Regulatory Affairs & Quality Assurance in Mexico. The role will support execution of regulatory activities for our client´s products, including preparation and coordination of submissions, lifecycle maintenance, regulatory correspondence, commitment tracking, and cross-functional follow-up.

The Director will remain the primary regulatory interface with COFEPRIS and will lead health authority meetings and strategic engagements; the Consultant will support preparation, documentation, and follow-up for those interactions rather than independently leading them.

This is a Full Service Provider (FSP) role sourced through Parexel and embedded in support of our organization. The position is based in Mexico City and follows a hybrid working model, with approximately 50% of working time expected in the Mexico City office.

Key Responsibilities

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

• Coordinate regulatory assessments and execution of CMC and manufacturing related changes affecting Mexico, including manufacturing sites, specifications, processes, analytical methods, packaging, and other post-approval changes, in close collaboration with Global Regulatory CMC, Quality and Supply Chain.

• Coordinate Mexico-specific labeling and artwork regulatory activities, including review of local prescribing information and packaging components, alignment with approved conditions, implementation of safety-related updates, and cross-functional coordination through approval and implementation.

• Demonstrated hands‑on experience supporting regulatory procedures before COFEPRIS, including preparation and follow‑up submissions, responses to queries, commitments, and post‑approval activities to support COFEPRIS interactions led by the Director.

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

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

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

• Maintain an integrated Mexico regulatory portfolio view, including registrations, submissions, approvals, commitments, renewals, post‑approval changes, authority requests, key dependencies and upcoming milestones; proactively identify items requiring Director attention.

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

• Ensure regulatory records, submissions, approvals, correspondence and commitments are appropriately documented and maintained in applicable regulatory systems and repositories in accordance with company procedures.

• Monitor Mexican regulatory requirements, COFEPRIS criteria, procedural updates and emerging practices; provide concise regulatory intelligence and impact assessments, and recommend operational actions, and support implementation of actions agreed with the Director.

• Work independently on assigned regulatory deliverables while operating within the regulatory strategy and authority‑engagement approach established by the Director.

• Own assigned regulatory activities end‑to‑end, proactively driving inputs, timelines, document readiness, follow‑up, and closure, while escalating strategic decisions, material risks, and authority‑sensitive matters to the Director.

• Support the Director, Regulatory Affairs & Quality Assurance – Mexico 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, as applicable to the Mexico affiliate.

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

Required Qualifications

• BA/BS degree in a scientific, engineering, pharmacy, healthcare, or related discipline

• 5+ years of progressively Regulatory Affairs experience in the pharmaceutical/biotechnology industry, with regulatory experience in Mexico strongly preferred

• Strong working knowledge of the Mexican regulatory framework and COFEPRIS procedures applicable to biologics products, including product registration and lifecycle maintenance

• Familiarity with current COFEPRIS submission pathways, administrative requirements, and electronic/digital processes

• Strong experience with CTD format and content of regulatory filings

• Experience preparing regulatory submissions, amendments, supplements, renewals, responses to health authority questions, and supporting documentation

• Strong organizational and project‑management skills, including the ability to prioritize multiple deliverables, maintain trackers, and meet regulatory timelines

• Strong written and oral communication skills in both Spanish and English

• Ability to work effectively in a cross‑functional, matrixed environment and to provide clear, timely operational support and escalation to the Director

• Experience authoring and reviewing regulatory documents and coordinating contributions from multiple functions

• Ability to work in a hybrid model in Mexico City, with approximately 50% of working time in the Mexico City office

Preferred Qualifications

• Master's, PharmD, or PhD degree

• Experience with vaccines, biologics, infectious diseases, or other complex products

• Familiarity with US, EU, or other reference‑agency regulatory frameworks, particularly where relevant to global alignment or reliance pathways

• Demonstrated ability to operate with a high degree of ownership and autonomy, anticipate regulatory needs, identify and resolve operational issues, and elevate strategic or authority‑sensitive matters appropriately

Parexel is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employee

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