Director, Regulatory Affairs, Ex-Us Larimar TherapeuticsDirector, Regulatory Affairs, Ex-UsPhiladelphia, PAPrepare Larimar impact assessment of global regulatory intelligence including but not limited to ICH and global Health Authority guidances, global Health Authority Pilot programs and initiatives, rare disease product approvals, and FDA advisory committee meetings. Larimar Therapeutics Inc. (Larimar) is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform.
Regulatory & Clinical Affairs Manager PEAK Technical Services Inc.Regulatory & Clinical Affairs ManagerPrinceton, NJ$150,000–$185,000 / yearThis individual will prepare and execute FDA, EU MDR, and international regulatory submissions while partnering closely with engineering, quality, and clinical teams throughout product development. Experience supporting Software as a Medical Device (SaMD), AI/ML-enabled medical devices, medical imaging, digital health, robotics, or surgical navigation products.
Regulatory Affairs Senior Manager LancesoftRegulatory Affairs Senior ManagerWarren, NJJob Purpose: The purpose of this role is to execute OTC regulatory activities for new product registrations and life-cycle Maintenance for the portfolio of products defined by the US Business Units. Provides advice on US-specific activities and ways of working and processes; Proactively identify potential risks and manage impact of regulatory changes within defined scope of.
NewAttorney Government and Regulatory Affairs Malamut & AssociatesAttorney Government and Regulatory AffairsCherry Hill, New Jersey$80,000–$150,000 / yearWith extensive experience, we deliver positive results for our clients, specializing in representing state, county, and local governments in a variety of matters, as well as clients in Personal Injury and Employment Law. Since our founding, the Firm has built a reputation for competent and ethical representation of our clients in matters of Personal Injury, Workers Compensation, Employment & Labor, and Government & Regulatory Affairs.
Senior Manager Regulatory Affairs US Advertising and Promotion - Immunology - Hybrid AbbVie IncSenior Manager Regulatory Affairs US Advertising and Promotion - Immunology - HybridFlorham Park, NJApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
Regulatory Affairs Expert - Remote YO AI LabsRegulatory Affairs Expert - RemotePhiladelphia, PennsylvaniaRemoteThe role involves assessing clinical documents, ensuring compliance with regulatory guidelines, identifying inconsistencies, and providing clear, evidence-based feedback to improve AI-generated regulatory content. We are seeking an experienced Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing and evaluating regulatory documentation.
Director, Regulatory Affairs Summit Strategic SearchDirector, Regulatory AffairsNew JerseyThe Director, Regulatory Affairs independently develops, coordinates, and executes global regulatory strategies across a portfolio that spans a commercial-stage asset and early-stage programs approaching their first regulatory filings. You will represent Regulatory Affairs on global cross-functional teams, interface directly with the FDA and other health authorities to align on development strategy, and guide programs from early development through registration and post-marketing.
Regulatory Affairs Coordinator Actalent IncRegulatory Affairs CoordinatorCamden, NJ$70,000–$100,000 / yearWe are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
NewScientist I - Regulatory Affairs Campbell'sScientist I - Regulatory AffairsCamden, New JerseyOur portfolio includes the iconic Campbell’s brand, as well as Cape Cod, Chunky, Goldfish, Kettle Brand, Lance, Late July, Pacific Foods, Pepperidge Farm, Prego, Pace, Rao’s Homemade, Snack Factory, Snyder’s of Hanover. Under general supervision, Regulatory Affairs Scientist I will support food product compliance by helping to ensure ingredients, formulas/recipes, labels, claims, and supporting documentation meet applicable food regulations, internal policies and customer requirements.
Associate, Regulatory Affairs- Labeling Sun Pharmaceutical Industries LtdAssociate, Regulatory Affairs- LabelingPrinceton, NJ$94,500–$105,000 / yearInitiate and provide approval for Artwork Approval Sheets for commercialization of artworks through Artwork Management System (AMS) for commercial products. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.
Regulatory Affairs Specialist, EHS, North America Henry Schein IncRegulatory Affairs Specialist, EHS, North AmericaNJ$56,604–$88,443 / yearDevelop and deliver employee environmental, health, and safety (EHS) awareness and training programs to ensure compliance with applicable federal, state, and international regulations, including OSHA, OSHA State Plans (e.g., Cal/OSHA), DOT, IATA, IMO, and EPA requirements. Proficient in Microsoft Office applications, including PowerPoint, and experienced with project management methodologies and tools commonly used in the medical device or pharmaceutical industries.
Director, Regulatory Affairs CMC Acadia Pharmaceuticals IncDirector, Regulatory Affairs CMCPrinceton, NJ$189,700–$237,100 / yearWe are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. In this leadership position, you will develop and execute global regulatory CMC strategies that support clinical development, marketing approvals, and lifecycle management across key regions including GCC, LATAM, and APAC.
Regulatory Affairs Specialist Amneal Pharmaceuticals, Inc.Regulatory Affairs SpecialistPiscataway, NJ$117,000–$120,000 / yearRegulatory Affairs Specialist: With minimal supervision assists with the preparation of high-quality regulatory submissions to the Food and Drug Administration (FDA) as required, within company timelines and in accordance with regulatory guidelines and applicable federal laws. Assists in organizing meetings with FDA including compilation of meeting requests and briefing packages with cross functional contributors.
Regulatory Affairs Project Manager F. Hoffmann-La Roche LtdRegulatory Affairs Project ManagerBranchburg, NJ$84,600–$157,200 / yearAs a Regulatory Affairs Project Manager you will have the opportunity to work with internal and external teams for project/product realization, write and prepare submission packets for health authority marketing approvals, and utilize agile principles to drive regulatory activities for our Oncology In-vitro Diagnostics (IVD) team. You value teamwork and collaboration and are able to pull people together around a common goal, seek to understand and build on different perspectives to enhance outcomes, and address and resolve conflict by creating an atmosphere of openness and trust.
Senior Director, Regulatory Affairs - Early Development/Business Development InsmedorporatedSenior Director, Regulatory Affairs - Early Development/Business DevelopmentNew JerseyRemoteResponsibilities will include strategic evaluation of regulatory risks and opportunities for external assets, assessing likelihood of technical and regulatory success, and contributing to the development and execution of global regulatory strategies for internal pipeline programs. You will provide regulatory input to global cross-functional project teams throughout the phases of product development and related submission activities and will serve as the global or regional regulatory lead on the projects.
Senior Manager Regulatory Affairs US & Canada Strategy Lead Therapeutic Neuroscience - Hybrid AbbVie IncSenior Manager Regulatory Affairs US & Canada Strategy Lead Therapeutic Neuroscience - HybridFlorham Park, NJApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
Senior Manager Regulatory Affairs US & Canada Strategy Lead - Therapeutic Neurotoxins - Hybrid AbbVie IncSenior Manager Regulatory Affairs US & Canada Strategy Lead - Therapeutic Neurotoxins - HybridFlorham Park, NJApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
Regulatory Affairs Manager Actalent IncRegulatory Affairs ManagerNJ$90,000–$115,000 / yearOversee the preparation, review, and maintenance of regulatory documents, including TDS, SDS, allergen and GMO statements, nutritional and natural certifications, Non-GMO Project forms, Kosher and Halal certifications, certificates of origin (COO), Prop 65 documentation, flavor labeling, TTB submissions, and related materials. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC-with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.
Regulatory Affairs Specialist Hybrid Spectrum VascularRegulatory Affairs Specialist HybridBridgewater, NJThis role collaborates cross-functionally with Quality, Engineering, Clinical, and Manufacturing teams to prepare, submit, and maintain regulatory filings with agencies such as the U.S. FDA, European Notified Bodies, and other international authorities. Innovation has been a core strategic pillar throughout our history and many of our products have been designed to deliver antimicrobial and antithrombogenic protection or to support certain patient populations such as those who are critically ill and pediatrics.
Regulatory Affairs Manager Hybrid Spectrum VascularRegulatory Affairs Manager HybridBridgewater, NJThis individual serves as a key regulatory lead within cross-functional teams and is accountable for ensuring that regulatory requirements are effectively translated into actionable plans and deliverables across the product lifecycle. This role combines strategic oversight with hands-on regulatory execution, including direct authorship of complex submissions (e.g., 510(k)s), regulatory assessments, and agency interactions.