Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Regulatory Affairs Manager

Omni Inclusive

Project Manager - Digital Optimization InitiativesThe Innovation Lab team partners with R&D stakeholders to design and deliver innovative analytics solutions that help them make better decisions, reduce costs and/or drive efficiencies. Our diverse analytics team of knowledge management experts, data scientists, analysts and data visualization specialists works on multiple projects simultaneously, ranging from piloting new capabilities, to developing cutting-edge approaches, to operationalizing complex solutions. We are looking for a passionate project lead who will be able to help drive innovation through the implementation of innovative solutions that provide insights to our stakeholders at the point of decision-making. Leading and in collaboration with our Innovation Lab team, this project lead will take accountability for all project phases including startup, execution and change management, ensuring the right solution is developed for the right stakeholder at the right time.Key Responsibilities/Abilities:Independently manages project scope, timelines, goals, strategy, and communication for projectsClearly and efficiently articulates potential risks, timelines, updatesIdentifies barriers, facilitating solutions and communicating to project sponsors timely and effectivelyDevelop stakeholder relationships and serve as key point of contact on projectsLeverage analytics techniques to use data to guide stakeholder and team decision makingProvides thought leadership to help design, execute, and implement analytics projectsSynthesize and communicate results to stakeholders and team through oral and written presentationsDesigns and implements custom insights and analytics to investigate and inform stakeholder needsTrains and effectively transitions projects to stakeholders, providing excellent customer service and efficient hand-offQualifications:BA/BS required2-4 years of relevant post-collegiate job experienceHigh motivation, strong work ethic, accountability and personal initiativePassionate about problem-solving, with demonstrated ability to identify root cause and work through challengesStrong written and oral communication skills; ability to frame issues and present to business stakeholders via PowerPoint, email, and other varied methodsAttention to detail and customer mindset - Applies global standards, models, and templates to drive innovation and consistency in analytics design and user experienceStrong desire to learn, willing to quickly build a strong background on critical and diverse topics related to the pharmaceutical industry (issues, trends) and be able to effectively identify opportunities and their potential business impactSelf-discipline for planning and organizing tasks, with ability to appropriately prioritize and act proactivelyPrior pharmaceutical experience a plus, but not required. Subject matter expertise in the project area is not required; however, passion for learning the subject matter enough to inform decisions is critical

Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Regulatory Affairs Manager in Princeton, NJ vacancy
  • Regulatory and Clinical Affairs ManagerPrimary Responsibilities:Regulatory Affairs• Preparation and execution of regulatory submissions, including...  ...regulatory assessments related to design changes, risk management, verification,validation, and clinical evidence.Clinical... 
    Suggested

    HealthCare Recruiters International

    Princeton, NJ
    7 hours ago
  • $145.6k - $279.4k

     ...Job Description Summary The Associate Director, Regulatory Affairs – Biosimilars (US) leads U.S. regulatory strategy and execution for biosimilar...  ...U.S. work‑visa sponsorship. Responsibilities Lead and manage the preparation, review, and submission of regulatory... 
    Suggested
    Work at office
    Visa sponsorship
    Work visa
    Relocation package

    U023 (FCRS = US023) Sandoz Inc

    Princeton, NJ
    1 day ago
  • $145.6k - $279.4k

     ...Associate Director, Regulatory Affairs - Biosimilars (US) Sandoz continues to go through an exciting and transformative period as a global...  ...role now or in the future. Job Description Leads and manages the preparation, review, and submission of regulatory applications... 
    Suggested
    Work at office
    Remote work
    Relocation package
    Flexible hours

    Sandoz International GmbH

    Princeton, NJ
    1 day ago
  • $196.7k - $353.4k

     ...seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader...  ...external to the company Demonstrated competence in employee management and development Knowledge of and broad experience with regulatory... 
    Suggested
    Permanent employment
    Full time
    Work at office
    Work from home

    Moderna Therapeutics

    Princeton, NJ
    7 hours ago
  • $121.1k - $181.13k

     ...POSITION SUMMARY The Compliance & Business Management (CBM) team supports key Pharmacovigilance operational, compliance, and business activities across the organization. The Manager, GPV Compliance & Business Management, executes and coordinates key operational components... 
    Suggested
    Contract work
    Temporary work
    Flexible hours

    Otsuka Pharmaceutical Co., Ltd.

    Princeton, NJ
    3 days ago
  • $110.9k - $157.9k

     ...believe we can have the biggest impact because: Together We Have the Power to Win.Job SummaryChurch & Dwight is seeking a Manager, Regulatory Affairs - Cosmetics (Global) to serve as the regulatory subject matter expert for cosmetic products and lead regulatory strategy,... 
    Full time
    Remote work

    Church & Dwight Company

    Princeton, NJ
    3 days ago
  •  ...Incredible opportunity to shape global regulatory strategy and deliver breakthrough science while working from home! We’re looking for a seasoned Regulatory Project Manager who can turn strategy into action and thrive in fast-moving, innovative environments. In this... 
    Work at office
    Remote work
    Work from home
    Worldwide

    PAREXEL

    Trenton, NJ
    5 days ago
  • $173.35k - $210.06k

    ## Associate Director, Commercial Regulatory AffairsPrinceton - NJ - USFind out how well you...  ...Director of US Commercial Regulatory Affairs requires the ability to apply complex scientific...  ...roles and development* Provide direct management to individuals depending on assignment*... 
    Hourly pay
    Full time
    Temporary work
    Part time
    For contractors
    Fixed term contract
    Summer work
    Live in
    Work at office
    Local area
    Remote work
    Flexible hours
    Shift work

    Jobleads-US

    Princeton, NJ
    3 days ago
  •  ...ll Spend Your Time:Assisting audit teams with planning and testing of franchisees and licensees’ compliance, financial and brand management, with the contractual obligations for all contract compliance auditsPerforming analysis of the franchisees and licensees’ financial... 
    Full time
    Contract work
    Work at office
    Local area

    Withum Smith+Brown

    Princeton, NJ
    3 days ago
  • $200k - $300k

     ...making significant contributions to the company's success. The Regulatory Affairs (Clinical/Nonclinical) role will drive regulatory strategy...  ...meetings and associated briefing document preparation Lead and manage queries and commitments with regulatory agencies, collaborate... 

    SystImmune

    Princeton, NJ
    2 days ago
  • $161.93k - $269.88k

     ...preferred. Work you'll do As an AI Governance & Assurance Strategy Manager on the Audit & Assurance team, you will be responsible for:...  ...& AssuranceDirectly align with enabling areas (e.g. PPN, Regulatory, Marketing & Comms, Sales Excellence) to ensure the AI Assurance... 
    Full time
    Local area
    Visa sponsorship

    Deloitte

    Princeton, NJ
    7 hours ago
  • $97k - $189k

     ...they matter and are part of something important, ensuring the abilities of all employees are used to their fullest potential. The Managing Director Strategic Claim Oversight leads the Severity & Excess Accounts team that both directly handles and oversees the highest exposure... 
    Full time
    Work experience placement
    Work at office

    CNA Financial

    Princeton, NJ
    7 hours ago
  • $142.5k - $256.5k

     ...changing the biotech industry.Reporting to the Director, Regulatory Information Management (RIM), the Associate Director, Regulatory Data Management...  ...business capabilities, and partner closely with Regulatory Affairs, Regulatory Operations, CMC, Labeling, Quality,... 
    Permanent employment
    Full time
    For contractors
    Work at office
    Work from home

    Moderna Therapeutics

    Princeton, NJ
    4 days ago
  • $212.5k - $250k

     ...Join Taiho Oncology as Director for Regulatory CMC Looking for a chance to make a meaningful difference in the oncology space? Taiho...  ...Position Summary: With minimal direction the incumbent manages the global regulatory CMC activities except Asia for all assigned... 
    For contractors
    Local area

    Taiho Oncology, Inc.

    Princeton, NJ
    2 days ago
  •  ...4,000 of us are challenging what’s possible and making headway to help improve outcomes.The Global Trade & Compliance Optimization Manager is an individual contributor responsible for driving compliant duty optimization and classification governance across Integra LifeSciences... 
    Full time

    Integra LifeSciences

    Princeton, NJ
    4 days ago
  • $101k - $112.5k

     ...applications such as: MS Word, MS Excel, MS Office, Windows, PowerPoint, Microsoft Outlook, Acrobat Reader, TrackWise, LMS (Learning Management System) etc.Knowledge of project management principles, practices, techniques and toolsStrong communication, interpersonal and... 
    Flexible hours

    Sun Pharmaceutical Industries

    Princeton, NJ
    2 days ago
  •  ...preparation and submission of Client global regulatory dossiers. Utilizes regulatory...  ...guidelines and requirements by planning, managing and overseeing the operational aspects of...  ...equivalent. A minimum of 2 years in regulatory affairs/operations is required. A minimum of a... 
    Work at office
    Night shift

    Artech Information System LLC

    Lawrenceville, NJ
    2 days ago
  •  ...Job Responsibilities Determine international regulatory submission and approval requirements Compile, prepare, review regulatory...  ...issues throughout the product lifecycle and collaborate with management and cross-functional team to develop solutions Provide regulatory... 
    Work experience placement

    Connecting Talent 2 Opportunity

    Princeton, NJ
    3 days ago
  • $187.1k - $327.5k

     ...senior leaders across Commercial, Medical Affairs, Market Access, Legal, Finance, HR, and...  .... Continuously monitor the external regulatory landscape to anticipate emerging risks and...  ...needs. Training & Culture Establish and manage a network of Ethics Ambassadors within assigned... 
    Local area
    Flexible hours
    Night shift

    BioSpace, Inc.

    Plainsboro, NJ
    2 days ago
  • $20 - $29 per hour

     ...contract offers a pay range of $20–$29 per hour, with 50% hybrid work (Mon-Wed onsite; Thu-Fri remote). You will develop dashboards using Smartsheet and Power BI and collaborate with cross-functional teams to ensure regulatory and quality readiness. #J-18808-Ljbffr... 
    Hourly pay
    Contract work
    Remote work

    Pride Global

    Princeton, NJ
    4 days ago
  •  ...the MLR system, collaborating with cross-functional teams to maintain documentation and compliant review cycles. The role involves managing submissions, maintaining records, and preparing materials for FDA submission, with opportunities to generate reports on KPIs and... 

    Sun Pharma

    Princeton, NJ
    2 days ago
  •  ...Regulatory Affairs Associate IIRegulatory contractor for data management including data entry, review and labeling revisions. Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance... 
    For contractors
    Work at office

    LanceSoft

    Princeton, NJ
    7 hours ago
  • $71.3k - $97.75k

     ...understanding of Export Administration Regulations (EAR), U.S. laws managed by the Bureau of Industry and Security (BIS) that control the...  ...Assist with maintenance of import/export programs. Monitor regulatory changes affecting import and export regulations, and surface... 
    Temporary work
    Work at office

    Integra LifeSciences

    Princeton, NJ
    2 days ago
  •  ...Sun Pharma in Princeton, NJ seeks a Regulatory Labeling Specialist responsible for preparing labeling submissions for ANDAs and reviewing...  ...labeling, creating Master Text for OTCs, maintaining product documentation, and supporting Life Cycle Management. #J-18808-Ljbffr... 

    Sun Pharma

    Princeton, NJ
    3 days ago
  • $86.7k - $102k

     ...our patients drives us to work collaboratively across various functions to achieve impactful results. The Regulatory Affairs Operations team creates and manages investigational and marketing applications to health authorities like the FDA and EMA, compiles required data... 
    Local area

    TAIHO ONCOLOGY INC

    Princeton, NJ
    2 days ago
  •  .... Beghou also deploys proprietary and third-party technology solutions to help companies forecast performance, design territories, manage customer data, organize, and report on medical and commercial data, and more. Headquartered in Evanston, Illinois, we have 10 global... 
    Remote work
    Flexible hours

    Beghou Consulting

    Princeton, NJ
    15 days ago
  • $160.88k - $241.32k

     ...solutioning. You will join an energetic, dedicated team of Project Managers based across US, DK and NL.The Associate Director, RDSI will...  ...abilities and critical thinking skills.• Familiarity with regulatory guidelines in development (preferred).For US based candidates,... 
    Full time
    Fixed term contract
    Work experience placement

    Genmab

    Princeton, NJ
    2 days ago
  • $119k - $218.3k

     ...Summary Senior Consultant - Risk, Regulatory, & Licensing - Digital Assets Regulatory...  ...s Digital Assets practice combines risk management, advanced regulatory knowledge, and...  ...certification(s) in risk, compliance, regulatory affairs, or a related field (e.g., CRCM, CAMS,... 
    Work at office

    Deloitte

    Princeton, NJ
    7 hours ago
  • $170k - $200k

     ...Bachelor's degree and at least ten years of experience in QA leadership within a pharmaceutical environment, ensuring successful regulatory inspections and quality standards. The position offers a salary range of $170,000 to $200,000 per year, eligible for an annual bonus... 

    Avet Pharmaceuticals Inc.

    Franklin Park, NJ
    5 days ago
  •  ...implementation, and successful execution of the scientific, operational, and regulatory reporting efforts in line with the overall WWPS needs. The PV Analytics and Reporting Specialist reports to the Senior Manager, PV Analytics Center of Excellence, within Global Biostatistics &... 
    Flexible hours

    Omni Inclusive

    Lawrence Township, NJ
    4 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Regulatory Affairs Manager. Be the first to apply!