We have other current jobs related to this field that you can find below
-
Lead Regulatory Affairs Consultant
7 days ago
Princeton, New Jersey, United States Intellectt Inc Full timePosition: Senior Regulatory Affairs SpecialistLocation: Princeton, NJContract Duration: 12 MonthsExperience Required: 3-5 years in Medical Device Regulatory AffairsEssential Skills:Proficient understanding of EU MDR regulationsKnowledgeable in Regulatory Change AssessmentExperienced with US and EU medical device submission processesBackground in supporting...
-
Lead Specialist in Regulatory Affairs
2 days ago
Princeton, New Jersey, United States KYYBA Full timePosition OverviewThis role is focused on enhancing regulatory compliance within the medical device sector. The successful candidate will collaborate with various departments to refine and advance regulatory processes.Experience Requirements:3-5 years of experience in Medical Device Regulatory Affairs.Proficient understanding of EU Medical Device Regulation...
-
Lead Regulatory Affairs Consultant
7 days ago
Princeton, New Jersey, United States Intellectt Inc Full timePosition: Senior Regulatory Affairs SpecialistCompany: Intellectt IncRole Overview:This role involves collaborating with various departments to enhance and refine regulatory affairs processes. The specialist will support the execution of strategies and operations related to regulatory affairs, which includes overseeing the preparation of product registration...
-
Lead Regulatory Affairs Consultant
7 days ago
Princeton, New Jersey, United States Intellectt Inc Full timePosition: Senior Regulatory Affairs SpecialistCompany: Intellectt IncKey Responsibilities:Engage with various departments to refine and enhance regulatory affairs methodologies.Support the execution of strategies and operations related to regulatory affairs, encompassing product registration submissions, status updates, and modifications.Revise and formulate...
-
Lead Regulatory Affairs Consultant
7 days ago
Princeton, New Jersey, United States Intellectt Inc Full timePosition: Senior Regulatory Affairs SpecialistCompany: Intellectt IncRole Overview: The Senior Regulatory Affairs Specialist will play a crucial role in overseeing and enhancing regulatory processes within the organization.Key Responsibilities:Engage with various departments to refine and improve regulatory affairs methodologies.Support the execution of...
-
Lead Regulatory Affairs Consultant
7 days ago
Princeton, New Jersey, United States Intellectt Inc Full timePosition: Senior Regulatory Affairs SpecialistCompany: Intellectt IncRole Overview: The Senior Regulatory Affairs Specialist will play a pivotal role in ensuring compliance with regulatory standards and enhancing operational processes within the organization.Key Responsibilities:Engage with various departments to refine and advance regulatory affairs...
-
Director - Regulatory Affairs - CMC & Compliance
1 month ago
Princeton, New Jersey, United States Novo Nordisk Full timeAbout the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product...
-
Lead Regulatory Affairs Consultant
7 days ago
Princeton, New Jersey, United States Techlink Systems Full timeJob OverviewPosition Title: Lead Regulatory Affairs ConsultantWork Schedule: Standard business hours, Monday to FridayROLE SUMMARY:The Lead Regulatory Affairs Consultant is responsible for integrating knowledge of scientific, regulatory, and commercial factors to ensure that i-STAT branded products developed, manufactured, or distributed by Point of Care...
-
Regulatory Affairs Director
2 days ago
Princeton, New Jersey, United States SUN PHARMA Full timeJob SummaryThe Director, Global Regulatory Lead will be responsible for leading the development and execution of regulatory strategies for assigned brand programs. This role will provide strategic, tactical, and operational direction and guidance for product's pipeline and key regulatory milestones.Key ResponsibilitiesServe as key corporate regulatory...
-
Lead Regulatory Affairs Consultant
7 days ago
Princeton, New Jersey, United States GTT, LLC Full timeJob OverviewPosition: Lead Regulatory Affairs ConsultantContract Duration: 12+ monthsCompensation: Up to $115/hrKey Responsibilities:The Lead Regulatory Affairs Consultant will leverage expertise in scientific, regulatory, and commercial aspects to ensure that i-STAT branded products comply with the necessary regulations in both the US and EU.This role...
-
Lead Regulatory Affairs Consultant
7 days ago
Princeton, New Jersey, United States Select Source International Full timeJob OverviewPosition Title: Lead Regulatory Affairs ConsultantLocation: RemoteContract Duration: 12 Month contract with potential for extension based on performanceThe role of a Lead Regulatory Affairs Consultant involves leveraging expertise in scientific, regulatory, and commercial matters to ensure that i-STAT branded products developed, manufactured, or...
-
Lead Regulatory Affairs Consultant
7 days ago
Princeton, New Jersey, United States Intellectt Inc Full timePosition: Senior Regulatory Affairs SpecialistCompany: Intellectt IncOverview: This role focuses on overseeing and enhancing regulatory processes within the organization.Key Responsibilities:Engage with various departments to refine and optimize regulatory affairs methodologies.Support the execution of strategies and operations related to regulatory affairs,...
-
Lecturer in Global Affairs
6 days ago
Princeton, New Jersey, United States The Trustees of Princeton University Full timePosition Overview:The Department of Politics is inviting applications for a tenure-track junior faculty role focused on global affairs. This position is designed for individuals who are well-qualified and passionate about the field.Responsibilities:The successful candidate will be responsible for teaching both graduate and undergraduate courses. We are...
-
Lead Regulatory Affairs Consultant
7 days ago
Princeton, New Jersey, United States Intellectt Inc Full timePosition: Senior Regulatory Affairs SpecialistLocation: RemoteDuration: Long-term ContractKey Responsibilities:This role involves collaborating with various departments to enhance and refine regulatory affairs processes. You will support the strategic implementation and operational activities related to regulatory affairs, including overseeing the...
-
Lead Regulatory Affairs Consultant
2 days ago
Princeton, New Jersey, United States Collabera Full timeJob OverviewKey Responsibilities:As a Lead Regulatory Affairs Consultant, you will leverage your expertise in scientific, regulatory, and commercial matters to ensure that products developed, manufactured, or distributed comply with the necessary regulations in both the US and EU.You will be recognized as a subject matter expert within your division,...
-
Lead Specialist in Regulatory Affairs
2 days ago
Princeton, New Jersey, United States KYYBA Full timePosition OverviewLead Specialist in Regulatory AffairsLocation: RemoteContract Type: Long-termWe are seeking a highly skilled professional to join our team as a Lead Specialist in Regulatory Affairs. This role is crucial for ensuring compliance and facilitating the regulatory processes for our innovative medical devices.Key Responsibilities:Expertise in In...
-
Manager - Regulatory Affairs - Therapeutic Area
1 month ago
Princeton, New Jersey, United States Novo Nordisk Full timeAbout the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product...
-
Head of Regulatory Affairs CMC
7 days ago
Princeton, New Jersey, United States Lynkx Staffing LLC Full timePosition OverviewOur esteemed client in the pharmaceutical sector is in search of a Director of Regulatory Affairs for Chemistry Manufacturing & Controls (CMC). This role is pivotal in steering global teams through the intricacies of regulatory strategy and the formulation of CMC elements within drug development initiatives. Collaboration with various...
-
Lead Regulatory Affairs Consultant
7 days ago
Princeton, New Jersey, United States Select Source International Full timeJob OverviewPosition: Senior Regulatory Affairs SpecialistCompany: Select Source International (SSI)Job Type: Contractual EngagementKey Responsibilities:Oversee the preparation and management of regulatory submissions for both US and EU markets.Ensure adherence to relevant Corporate and Divisional Policies within the quality management framework.Proactively...
-
Lead Regulatory Affairs Consultant
2 days ago
Princeton, New Jersey, United States KYYBA Full timeJob OverviewPosition Summary: The individual in this role will be accountable for the preparation and upkeep of US 510k submissions and EU IVDR Technical Files, ensuring adherence to relevant Corporate and Divisional Policies and quality system protocols.Key Responsibilities:Compile, prepare, and evaluate regulatory submissions for both US and EU...
Regulatory Affairs Manager/Personal Care-Princeton
2 months ago
Regulatory Affairs Manager/Personal Care
Princeton, NJ, US
Hybrid
Are you passionate about the cosmetic and OTC sunscreen regulations in North America with a customer centric mindset? Join us in our journey
As a Regulatory Affairs Manager North America (NA), you will be part of a cross-functional team located in North America, working closely with a Global team in Switzerland. Your corporate office location is in Princeton for the Perfumery & Beauty BU with the possibility to work part-time remote. The activities linked to the position are highly complex due to the dynamics of the Personal Care and Sunscreen market and changing regulatory environment in NA. Your responsibility will encompass the integration of Marketing and Sales plans into a regulatory strategy program and its implementation. You will be part of a highly professional and motivated team.
At dsm-firmenich, being a force for good is not optional. Diversity, Equity & Inclusion is a shared responsibility woven into our daily work, benefiting to our People, Customers & Communities and driving business value. Equal access to opportunities is a given, belonging is a shared feeling, authenticity is celebrated.
Your key responsibilities
- Lead and manage NA regulatory activities defined by manager, including guaranteed market clearance for the import to Canada and USA, sunscreen drug listing at FDA and compliance with Proposition 65 and USP.
- Work across the RA organization to ensure that ingredients designed to OTC sunscreen actives, vitamins, skin and hair care actives and personal care specialty chemicals products are evaluated for safety and regulatory conformance
- Support the joint efforts of the Personal Care (PC) business in NA by providing RA guidance to the internal teams and customers and provide clearance for promotional materials.
- Collaborate cross-functionally with marketing, sales, quality, R&D and safety to ensure alignment of activities and accuracy of communications related to the regulatory, scientific and technical status of personal care products and being integrated to the global regulatory team.
- Contribute to the development of the NA regulatory strategy for new product innovations which will be led by manager. Support submissions related to OTC sunscreen actives at FDA or Health Canada if required and in line with the global PC strategy and as part of a global innovation team.
- Responsible for handling regulatory aspects of customer queries related to PC products and NA. Monitor and report changges in the regulatory environment and assess their impact on the business.
We bring
- A rich history and a promising future of bold scientific innovation and passionate creation with our customers;
- A space to grow by encouraging and supporting curiosity and an open mindset;
- A culture that prioritizes safety and well-being, both physically and mentally;
- The opportunity to work for a company where sustainability is much more than a claim and is core to our strategy and purpose;
- A flexible work environment that empowers people to take accountability for their work and own the outcome;
- Barrier-free communities within our organization where every employee is equally valued and respected – regardless of their background, beliefs, or identity;
You bring
- Master's degree / University degree in science.
- At least 3 to 5 years' experience in Regulatory Affairs, ideally in OTC sunscreen market.
- in-depth interdisciplinary knowledge in the areas such as Analytics, Chemistry and Production, Biology and Toxicology.
- Proven experience working in cross-functional teams and with multiple stakeholders inside and outside at all levels
#ext