Consultant, Regulatory Affairs and Quality

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 escalate 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 escalate 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