Role: Senior Regulatory Affairs Specialist. Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR. Assist the strategy implementation and operations for regulatory affairs activities, including directing development of product re...
The Regulatory Affairs Lead will be responsible for ensuring compliance with all regulatory standards and guidelines, leading the preparation and submission of regulatory documents, and overseeing the development of generics including Risk Evaluation and Mitigation Strategies (REMS) programs. Our cl...
Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR. Assist the strategy implementation and operations for regulatory affairs activities, including directing development of product registration submission, progress reports, sup...
We currently have an opening for a Regulatory Affairs Specialist II. This position is responsible for Regulatory Affairs support of submissions and on-going regulatory compliance for product development process. Acts as a core team member on development teams, providing Regulatory Affairs feedback a...
Senior Staff Regulatory Affairs Specialist. As the Senior Staff Regulatory Affairs Specialist, you will work to maintain medical devices on the market and ensure ongoing compliance. You will participate on cross-functional teams, develop global regulatory strategies, author regulatory submissions, i...
They engage in correspondence, meetings, and interactions with the FDA to address regulatory inquiries, respond to requests for additional information, and seek clarification on regulatory matters under the guidance of the Director, US Market Access. Analyzes and communicate the adequacy of proposed...
Prepare new and maintain existing regulatory files in accordance with regional requirements, including but not limited to document updates, management of regulatory information in databases, and navigating document control systems. Review regulatory content for completeness, accuracy, consistency, a...
Eligibilities & qualifications....
Konica Minolta is actively searching for a Contract Compliance Specialist for our Ramsey, NJ headquarters! This individual will actively participate in contract needs assessments with internal and external stakeholders, interface with multiple departments in the company such as Legal, Credit, Finan...
VNS Health is seeking a Registered Nurse (RN) Manager, Program Manager for a nursing job in Cliffside Park, New Jersey. Posted job title: Specialized Products And Program Manager. Manages the day-to-day activities of one or more of the Population Health specialized programs or products. Supervises t...
Animal Care/Use Compliance Specialist. Animal Care/Use Compliance Specialist. Additionally, this role may lead less experienced specialists and provide regulatory guidance to investigators. Maintains all related records in compliance with HMH SOPs and regulatory requirements. ...
Builds the skills of the project management organization to include strong program and project governance and delivery skills. Project credentials such as PMP or at least 5 years of hands on project management experience. Experience with demand management, PMO processes including project tools such ...
Regulatory Affairs Senior Manager is responsible for leading the regulatory strategy and managing the regulatory compliance in Personal Care and Cosmetics. This position will report directly to the Global Director Regulatory Affairs. Lead and enhance the regulatory program to enable the business wit...
As a Barclays Project Manager - Vice President, you will have the chance to support our mission in creating an environment of effective delivery and providing a broad range of business and technical skills to create a high-level outcome for our stakeholders. To manage change projects that help the o...
As a Technical Business Analyst, you will play a key role in the delivery of business requirements. Strong experience working with Trade Surveillance, Compliance, Regulatory Reporting. Work closely with the Compliance Stakeholders to ensure functional / Technical requirements are clearly specified. ...
Global Regulatory Affairs Operation Sr. This position belongs to Global regulatory affairs department, serving the global Market which encompasses China US, EU, AUS and others. This role requires a detail-oriented professional who can oversee all regulatory affairs and quality assurance activities, ...
Escalate program risks to the Program Director or Program Sponsor as appropriate. Plan, direct, and coordinate day-to-day activities for running a program or a portfolio of programs. As part of our Enterprise Risk Technology team, you will play a crucial role in managing the program aspects of our E...
Regulatory Affairs AD/Director – Labeling. This person will oversee the US Regulatory Labeling activities and processes for regulatory submissions and product maintenance. The RA AD/Director will be responsible for building the team and then leading and managing its growth and development. ...
The Compliance Data Analyst I will report to the GRC Senior Compliance Associate, and assist with ongoing data remediation, data quality checks, license verification from respective state boards to ensure federal, state and EU disclosure reports are reported timely and accurately on behalf of OAPI a...
Do you have an eye for detail and a passion for developing innovation solutions? Join our team! The Sr Supply Chain Compliance Systems Analyst is responsible for overseeing the compliance of SNC's Source-to-Pay (S2P) system areas such as application development, application compliance, systems compl...
Contribute in interpreting regulations and assisting internal & external stakeholders with product stewardship and regulatory compliance. Assist in the development of global strategies and compliance programs for raw materials and product evaluations. Experience with regulatory compliance tool and s...
Catalent Pharma Solutions in Somerset, NJ is hiring a Senior Regulatory and Compliance Specialist for the Compliance Group. The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry and their impact on manufacturin...
The Senior Project Manager leads the projects through building effective relationships with business leaders, project team and project stakeholders. The Senior Project Manager drives the delivery of the projects/program through advanced project management techniques and methodologies. The Senior Pro...
The Senior Regulatory Affairs Associate/Manager plays a key role in ensuring compliance with regulatory requirements that govern the development, registration and commercialization of livestock and poultry products (primarily medicated feed additives and water-soluble products) while also providing ...
Regulatory Affairs Senior Manager is responsible for leading the regulatory strategy and managing the regulatory compliance in Personal Care and Cosmetics. This position will report directly to the Global Director Regulatory Affairs. Lead and enhance the regulatory program to enable the business wit...