CMC Regulatory Affairs Senior/Consultant

Cmc Regulatory Affairs Senior/ConsultantExciting opportunity for an experienced and highly motivated professional to join our global regulatory affairs team. This role is critical to ensure our client's investigational, new, and marketed small molecule products are developed and maintained in compliance with global regulatory requirements. The primary regions of responsibility include the United States, European Union, and Canada, with a focus on facilitating timely approvals and supporting continued market access.Key ResponsibilitiesStrategic Cmc LeadershipProvide regulatory strategy input for small molecules (previous experience with biologics and/or drug-device combination products are a plus)Support regulatory leads in developing contingency plans for Cmc-related scenariosRepresent Cmc regulatory affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global regulatory leadsSubmission & Documentation ExcellencePrepare, coordinate, and review Cmc and Gmp-related documents for regulatory submissionsDevelop Cmc strategies for products across all phasesfrom early development to marketing applications and post-approval changesCross-Functional CollaborationPartner with manufacturing, quality, and external organizations to address Cmc-related issuesMaintain collaborative relationships with internal stakeholders, affiliates, contract manufacturers, packagers, and suppliersSupport planning and execution of health authority meetings, including mock sessionsProcess Optimization & InnovationIdentify and implement process improvements to enhance regulatory efficiency and readinessParticipate in monthly Cmc global regulatory team meetings to align strategies across functionsUtilize regulatory systems and tools including Credo, Trackwise Digital, and TRS Viewer Regulatory SystemsRegulatory Systems & ReportingExperience with CPP application filing via eCATS and 510(j)(3) reporting through nextGen portals is a plusEnsure audit readiness and version control through meticulous documentation and system managementQualificationsExperience & Expertise46 years of Cmc regulatory experience in the pharmaceutical industry for a consultant level role, 7+ years for a senior consultantProven success in preparing regulatory documentation for FDA, EMA, and Health Canada (IND, NDA, DMF)In-depth understanding of drug development, manufacturing processes, GMP, and regulatory frameworks for small molecules. Previous experience with biologics or combination device products are a plusSkills & AttributesStrategic and proactive mindset with strong operational executionExcellent analytical, problem-solving, and negotiation skillsEffective communicator with strong interpersonal, presentation, and leadership abilitiesAbility to manage multiple projects independently in a matrixed, multicultural environmentProficiency in Microsoft Office Suite and regulatory systemsEducationBachelor's degree in pharmaceutical sciences, chemistry, or related fieldAdvanced degrees (Pharm.D., M.S., Ph.D.) in pharmaceutics, biochemistry, molecular biology, biotechnology, or biology preferredRAC certification is a plusGiven the client's location, preference will be given to candidates residing in the eastern time zone. However, exceptional individuals based on other time zones will also be considered, provided they can accommodate the scheduling requirements of global meetings and calls as needed.Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.