Manager / Sr. Manager, Regulatory Strategy & Program

Job Title: Manager / Sr. Manager, Regulatory Strategy & Program Reports to (Title): Head of Global Regulatory AffairsLocation: NJExempt/Non-Exempt: ExemptDepartment: Global Regulatory AffairsEEO Job Category: Professional HengRui USA is the US hub for our parent company Jiangsu Hengrui Medicine (600276 SHA), a global pharmaceutical company with around $90 Billion market value, $3.6 Billion annual revenue (data by 2019) and over 30,000 employees globally. The product line includes antineoplastic drugs, angiomyocardiac drugs, surgical drugs, contrast agents and antibiotics. The pipeline across different therapeutic areas such as oncology, autoimmune, pain management, metabolics etc.In HengRui USA, we recognize, appreciate, and reward our team’s contributions; we emphasize our people’s well-being. We want you to feel empowered to do your best work, in a place where you are respected, engaged, fulfilled, and developing! Job Summary:The Sr. Manager, Regulatory Strategy & Program Management supports the strategic planning, coordination, execution, and oversight of regulatory submissions across the U.S., Europe, and global markets.This role serves as a key cross-functional regulatory leader within Global Regulatory Affairs, responsible for driving submission readiness, managing complex regulatory timelines, coordinating internal stakeholders, and overseeing external publishing vendors to ensure high-quality, timely, and compliant submissions to FDA, EMA, and other global health authorities.Rather than functioning primarily as a hands-on publisher, this position acts as the regulatory submission lead and program manager, partnering closely with Global Regulatory Leads, Clinical Development, CMC, Safety, Quality, and international teams to support major submissions and lifecycle management activities..Essential Job Functions:Lead strategic planning, coordination, and execution of regulatory submissions for INDs, NDAs, BLAs, MAAs, IMPDs, and lifecycle management activities across the U.S., EU, and global markets. Serve as the regulatory program lead for major submissions, ensuring alignment of regulatory strategy, content planning, timelines, responsibilities, and submission readiness. Partner closely with Global Regulatory Leads (GRLs) and regional regulatory teams to support global regulatory strategy execution across development and commercial programs. Support regulatory interactions and submission planning for FDA, EMA, and other health authorities, including scientific advice, pre-submission meetings, and responses to agency questions. Coordinate cross-functional submission teams including Regulatory Affairs, Clinical, CMC, Nonclinical, Pharmacovigilance, Biostatistics, Quality, and external partners. Manage external publishing vendors responsible for eCTD publishing, validation, electronic submissions, and regional submission requirements. Provide strategic input on submission timelines, publishing plans, dossier structure, module ownership, and submission execution plans. Review submission packages for completeness, quality, consistency, and compliance with FDA, EMA, and ICH requirements. Ensure effective lifecycle management, tracking, archiving, and inspection readiness for all regulatory applications and submission records. Support EU-specific regulatory activities including MAA preparation, variation management, responses to Day 120/180 questions, CHMP support activities, and post-approval lifecycle management. Identify process improvements, system enhancements, and operational efficiencies across regulatory strategy, submission management, and vendor oversight. Maintain submission standards, document templates, and regulatory operational best practices across development programs. Provide guidance and training to internal teams on submission planning, documentation standards, and regulatory execution excellence.Job Requirements:Strong understanding of global regulatory submission strategy, program management, and health authority requirements. Deep knowledge of FDA, EMA, and ICH requirements across development, registration, and post-marketing lifecycle management. Experience leading complex cross-functional submission teams for major filings and health authority interactions. Strong experience supporting both U.S. and EU regulatory submissions, including FDA and EMA procedures. Experience managing external publishing vendors and ensuring high-quality regulatory execution. Excellent organizational, communication, stakeholder management, and influencing skills. Ability to manage multiple high-priority programs simultaneously in a fast-paced global environment.Experience / EducationBA/BS degree required; advanced scientific degree preferred 8+ years of pharmaceutical industry experience 6–8+ years of experience in Global Regulatory Affairs, Regulatory Program Management, or Submission Management Strong experience supporting major submissions including INDs, NDAs, BLAs, MAAs, IMPDs, and post-approval lifecycle management Knowledge / Skills / Abilities:Strong familiarity with FDA, EMA, and ICH guidelines related to regulatory submissions, clinical development, and marketing applicationsSolid understanding of U.S. and EU submission requirements, including eCTD structure, MAA preparation, lifecycle management, and variation handlingExperience with EDMS platforms (Veeva Vault preferred), regulatory submission systems, and global document management processesStrong understanding of submission content, dossier strategy, and regulatory program executionExperience managing submission vendors and driving accountability across external partnersStrong project management, risk identification, problem-solving, and decision-making capabilitiesExcellent written and verbal communication skills with the ability to influence across functions and senior leadershipSelf-motivated, highly organized, detail-oriented, and able to work independently while driving team executionBenefits:We offer a comprehensive benefits package including medical, dental, and vision insurance; paid time off; a 401k retirement plan with company match. Company paid Life Insurance plan. Additional voluntary benefits (e.g., FSA, DCSA, supplement life insurance, etc.) are available.Schedule: Monday to FridaySalary Range: $145 - $180kAn Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability