Director, Regulatory Strategy - FDA Products

DESCRIPTIONDriven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team!POSITION PURPOSEThe Director of Regulatory Strategy for FDA Products will develop and execute regulatory strategies that drive business innovation while ensuring regulatory compliance. This role will provide leadership and guidance for regulatory submissions, health authority interactions, new product development, and existing product maintenance as well as oversee routine regulatory operations. The ideal candidate will combine strong regulatory knowledge with hands-on experience to ensure regulatory compliance over the full life cycle of a diverse portfolio of healthcare and consumer regulated drug, device, and cosmetics under FDA jurisdiction.ESSENTIAL FUNCTIONS AND BASIC DUTIESContributionsLead FDA Products Regulatory team in developing and executing regulatory strategies for new product development, business development & licensing opportunities, and post-marketing changes to ensure successful commercialization across product life cyclePrepare, submit and maintain new IND/NDA, and 510(k) marketing authorization applicationsDevelop and maintain strong relationships with FDA project managersRepresent Regulatory Affairs in cross-functional new product development (NPD) teamsDevelop and maintain strong, collaborative partnerships with R&D, Clinical, Quality, Legal Marketing, Operations and Project ManagementPrepare regulatory pathway options, identify project risks and support project teams in risk mitigation strategiesRegulation and Guidance:Identify, communicate and provide support to R&D, Clinical, Quality and other functions in interpretation and application of relevant guidance and regulationLead and influence cross-functional teams to ensure technical data and information is accurate, complete and on-time to meet submission timelinesReview and approve technical documents (protocol, reports, specifications) to ensure complete, accurate and in compliance with relevant regulationsReview change controls to assess reportabilityAuthor and review regulatory documents for IND, NDA, and 510(k) submissionsPrepare, submit and maintain ARs for FDA IND and NDA drug productsSupport Pharmacovigilance in assessing reporting requirements for AEs, review and submit PADERs and PBRERsMaintain complete and accurate IND, NDA, 510(k) chronology logs and documentationCollaborate with cross-functional team in the review and approval of labeling, advertising and promotional materialMonitor trends, emerging regulations, guidance, and best practices related to product development and complianceTranslate regulatory intelligence and trends into proactive, actionable guidanceRepresent PDI at industry meetingsEnsure products meet all relevant Federal regulations and reporting requirements for U.S. and CATrain, mentor, and oversee 1 direct reportAssist in Agency inspections and audits as necessaryCross-Functional SupportCollaboration: Work closely with multidisciplinary teams, including R&D, Clinical, Operations, and Quality functions to integrate regulatory requirements into the overall drug development strategy, align regulatory submissions with development and operational plans, and ensure project timelines are metProblem Solving: Generate hypotheses and investigative strategies to address product development or compliance challengesParticipate: in health authority interactions (FDA, Health Canada) by preparing meeting materials and response strategiesOperational ExcellenceMaintain and strengthen regulatory documentation, templates, and SOPs to support consistent, high-quality regulatory assessments and strategiesPartner with cross-functional colleagues to identify process improvements and leverage tools that enhance efficiency and accuracy in development and maintenance projectsMentorship and CollaborationProvide guidance and support to junior regulatory staff where applicable, sharing expertise and best practicesFoster collaborative relationships internally and with external partners/sponsorsPERFORMANCE MEASUREMENTSAchievement: Consistent delivery of complete, accurate and on-time high-quality regulatory strategies and project deliverablesOwnership: Independent and proactive management of assigned projects to ensure complete, accurate and timely completionCollaboration: Effective teamwork and communication across functions to achieve shared objectivesInnovation: Introduction of creative solutions and contributions to process improvements and new product ideasBusiness Acumen: Effective balancing of compliance risk with commercial goalsQUALIFICATIONS:EDUCATION/CERTIFICATIONBS, MS, PhD, or PharmD degree in life sciences or pharmacy; RAC certification a plusREQUIRED KNOWLEDGESignificant knowledge and working experience in drug development, submissions and FDA interactionsSignificant knowledge of 21 CFR 312/314, 21 CFR 820, cGMPs, QSRs, FDA Guidance and best practices in drug and device development and maintenanceEXPERIENCE REQUIRED10 -12 years of FDA regulatory experience in drug and medical device development and approval/clearance processesDemonstrated experience in developing and executing regulatory strategies for new drugs and medical devicesDemonstrated experience in obtaining approval for new drugs via the IND/ NDA pathwayDemonstrated experience in obtaining clearance for 510(k) medical devicesExperience preparing and leading meetings with FDADESIRABLESExperience in combination Drug + Device products a plusExperience in Cosmetics and OTC Monograph drugs a plusSKILLS/ABILITIESStrong organizational skills with attention to detail, quality, and timelinesExcellent written and verbal communication skills; ability to work in cross-functional teamsExcellent organizational, prioritization abilities, tracking and follow-up skillsAbility to complete projects on time and handle multiple parallel projects in a fast-paced environmentGood analytical and problem-solving abilities, communication and interpersonal, and record keeping skillsStrong attention to detailAbility to handle multiple tasks / projects simultaneously and bring them to completion on timeSelf-starter with ability to think and act independently and to make sound decisionsFast learner with a flexible style and the ability to adjust to changing business prioritiesAbility to interface with internal and external contacts at all levelsGreat flexibility and ability to work well with shifting prioritiesWORKING CONDITIONSEnvironment: Corporate office with on-site R&D laboratoriesWork Schedule: Hybrid (4-days/week onsite, 1-day/week remote)SALARY RANGE$170,000 - $200,000 annuallyBENEFITSMedical, behavioral & prescription drug coverageHealth Savings Account (HSA)DentalVision401(k) savings plan with company match and profit sharingBasic and supplemental Life and AD&D insuranceFlexible Spending Accounts (FSAs)Short & long-term disabilityEmployee Assistance Program (EAP)Health Advocacy ProgramPDI also offers many voluntary benefits such as: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts.At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including: sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThis employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.J-18808-Ljbffr