As the Regulatory Affairs Operations Specialist, Ad/Promo, you will play a pivotal role in ensuring regulatory compliance and operational efficiency within our organization. Strong understanding of Regulatory Operations processes and systems including Regulatory Information Management & Document/ Da...
A company is looking for a Regulatory & Compliance Specialist in the healthcare ecosystem. Key Responsibilities:Track state and federal legislation and regulations affecting clientsUpdate bills and rules in the online softwareMonitor Board of Pharmacy websites for relevant informationRequired Qualif...
The Regulatory Affairs Specialist- Contractor will assist or lead a variety of regulatory tasks in support of global. Perform regulatory assessments for product changes including regulatory reportability decisions. Work with cross functional team and international regulatory colleagues to develop an...
Key Responsibilities:Plan, coordinate, and drive the development and evaluation of regulatory strategies and submissionsManage resources and provide regulatory leadership and mentoringConduct quality audits, develop management systems, and represent projects at various meetingsRequired Qualification...
Participate in the preparation and review of regulatory submissions to the US FDA and international (outside the US) regulatory authorities. Participate in the development of regional regulatory strategy and update strategy based on regulatory changes. A minimum of 5 years of experience in medical d...
Our client, a large healthcare company is seeking a Regulatory Affairs Specialist to join their team! As the Regulatory Affairs Specialist you would provide regulatory support and expertise by developing global regulatory strategies, identifying needed registration data, obtaining this data and ensu...
We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and commercial, and affiliate personnel in the medical device industry. Regulatory Affairs Specialist– Santa Clara, CA. Assi...
As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. This Senior Regulatory Affairs Specialist position is an on-site opportunity working out of o...
We are currently seeking a highly motivated Regulatory Affairs Specialist to join our Regulatory Affairs department. Qualified individuals will be responsible for collection and coordination of regulatory documentation for submission to regulatory and business partners. Assist with the collection, c...
Required Skills:Regulatory Escalations Specialist Responsibilities:Serve as an expert on enforcing Meta’s Community standards and policies, including regulatory policies and region specific social media legislation where required. Summary:Meta is seeking an Escalations Specialist to join the Detecti...
Senior Regulatory Affairs Specialist . Senior Regulatory Affairs Specialist. Provides regulatory input and technical guidance on global regulatory requirements to product development teams. Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team. ...
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs.Ardelyx has two commercial products approved in the United States, IBSRELA®(tenapanor) and XPHOZAH® (tenapanor), as well as early-stage pipeline ca...
In this role, you will… Perform regulatory assessments for product changes including regulatory reportability decisions Work with cross functional team and international regulatory colleagues to develop and implement global regulatory strategy to support business global expansions Support regulatory...
The Sr Regulatory Affairs Specialist is responsible for ensuring digital medical device regulatory clearance to enable market access by demonstrating compliance to applicable regulations through a registration dossier. Provides regulatory guidance and defines regulatory strategy for digital products...
Senior Staff Regulatory Affairs Specialist. Senior Staff Regulatory Affairs Specialist. You will be responsible for regulatory agency communications regarding pre-submission strategies/ regulatory pathway development and submission. Serve as a regulatory affairs representative to improve awareness, ...
Responsibilities also include keeping senior management informed of regulatory status of products and significant regulatory issues as well as maintain proficiency in global regulatory requirements. Principal Regulatory Affairs Specialist. Proven expertise in all aspects of Regulatory Affairs; Strat...
Collaborate with cross-functional teams to drive regulatory project management activities. Manage timely completion of new product registrations and maintain global regulatory approvals to market software devices. Collaborate with external partners including regulatory agencies, authorized represent...
Support regulatory submission strategies and update as needed through investigation and evaluation of regulatory history/ background, classification, disease, and/ or harmonized/ recognized standards, in order to assess regulatory implications for approval. Develop and maintain positive relationship...
ERM has an opportunity for an experienced biologist/regulatory specialist to join our thriving global consulting firm as a . Principal Biologist/Regulatory Specialist. Principal Biologist/Regulatory Specialist. Serve as Project Biologist/Regulatory Specialist for environmental impact assessment unde...
Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also keeps...
The Principal Regulatory Affairs Specialist hired will report to the Senior Director of Regulatory and Quality, with sights to build out an RA team as needed. Support and prepare all regulatory submissions for FDA, Health Canada, Notified Bodies, and other regulatory agencies, with limited guidance ...
Represents RA in new product development team(s) by providing regulatory guidance, such as anticipating regulatory obstacles and emerging issues, and identifying solutions, through the product development cycle and coordinating cross functional team inputs. Responsible for assessing and documenting ...
Regulatory Affairs Specialist II. Regulatory Affairs Specialist II:. Regulatory Affairs Specialist II:. Works in close collaboration with internal customers and supports multiple projects to align on regulatory strategy to achieve business objectives. ...
Senior Regulatory Affairs Specialist (Multiple Positions), Becton Dickinson and Company, Milpitas, CA. Apply deep understanding of global regulatory landscape to analyze and compile country-specific regulatory requirements. Participating in setting regulatory operation process, including the regulat...
We are currently seeking a highly motivated Regulatory Affairs Specialist to join our Regulatory Affairs department. Qualified individuals will be responsible for collection and coordination of regulatory documentation for submission to regulatory and business partners. Assist with the collection, c...