When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health.
From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient.
We take our work personally, we do it with empathy and we're committed to making a difference.Consultant of Regulatory StrategyAbout ParexelParexel 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 OverviewThis 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 ResponsibilitiesRegulatory Strategy & DevelopmentPartner with global regulatory leads, regulatory strategists, Global Regulatory Sub-Teams,



and project teams to develop and execute regulatory strategy throughout the product development lifecycleIdentify and assess regulatory risks for assigned projects or programsServe as point of contact with regulatory agencies relevant to assigned projects or programs, as appropriateRegulatory Submissions & DocumentationCoordinate, develop, and contribute to the content and format of regulatory submissions and related supplements and amendmentsManage submissions including:FDA meeting requests and briefing booksINDs (Investigational New Drug applications)CTAs (Clinical Trial Applications)Pediatric plansDSURs (Periodic Safety Update Reports)MAA/BLA/NDA (Marketing Authorization Applications, Biologics License Applications, New Drug Applications)Orphan drug designationsOther regulatory submissions as neededAdministrative & ComplianceTrack, follow up, and archive correspondence with Health AgenciesMonitor and document regulatory commitments and queries from Health AuthoritiesMaintain accurate regulatory records and documentationCollaboration & Project ManagementWork both independently and within project teams, committees, and cross-functional groups to achieve organizational goalsDemonstrate strong organizational skills and ability to prioritize workload effectivelyRequired QualificationsEducation: 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 experienceRegulatory Expertise: 3+ years of regulatory strategy experience or relevant equivalent training/experienceTechnical 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 documentsPreferred QualificationsExperience in Infectious Diseases and/or BiologicalsDemonstrated expertise in preparing regulatory submissions and supportive amendments or supplementsKnowledge of applicable regulations across multiple jurisdictionsRequired CompetenciesCommunication: Exceptional written and oral communication skills in both English and SpanishOrganization: Strong organizational abilities with proven capacity to manage multiple prioritiesIndependence & Collaboration: Ability to work autonomously while effectively contributing to team objectivesAttention to Detail: Meticulous approach to regulatory documentation and complianceThis position offers an opportunity to play a critical role in bringing infectious disease treatments to market across Latin America while working with a general regulatory team.
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📌 Regulatory Affairs Consultant - Regulatory Strategist (Chihuahua)
🏢 Parexel
📍 Chihuahua