Regulatory Affairs Specialist: salario promedio en Florham Park, NJ in 2024

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...

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...

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...

This role will be accountable for leading the development and execution of innovative and value-added global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS) for immunology products in Early Development. At least 8-10 years of relevant pharmaceut...

Coordinate with the team to monitor the progress of certain products submitted by Ostend Regulatory Affairs departments. Coordinate regulatory activities with internal teams and external regulatory agencies. Manage the day-to-day activities of less senior Regulatory Affairs professionals, including ...

As a Quality & Regulatory Affairs Specialist (m/w/d), you will be in charge of providing support to Capital Equipment servicing as well as to EMEA Quality and Regulatory Organisation to ensure quality and regulatory compliance. ...

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...

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...

Regulatory Affairs Specialist Project Lead I (Scientific). This role will be accountable for leading the development and execution of innovative and value-added global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS) for immunology products in Ea...

Hiring - Senior Regulatory Affairs Specialist. Assess applicable change requests for regulatory impact and follow-up on related regulatory action items. Support marketing, R&D and Lonza BU in ad hoc projects, in relation to market growth and innovation initiatives by preparing US regulatory assessme...

Senior Principal Regulatory Affairs Specialist. Responsible for the overall product strategy, reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance, regulatory intelligence and change management for consumer products (Rx/OTC, OTC Monograph,...

Prepare new/revised label packaging for regulatory submissions to the USDA and maintain regulatory documents to ensure site compliance. Support regulatory filing submissions with the USDA for both domestic and international product packaging. ...

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As a Construction Inspector/ Project Manager on our Civil/Site Work team you will be responsible for providing project support and conducting on-site inspections to ensure compliance with project plans, specifications, and industry standards. We have an immediate opening for a Civil/Site Work Constr...

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. ...

Corporate - Legal and Compliance. Lead special assignments and perform targeted investigations on potential financial crime concerns to support the Compliance function. Contribute to financial crimes compliance policies, procedures, processes, and training. Track compliance issues to completion and ...

Escalates program risks to the Program Director, or Program Sponsor, when appropriate. Supports planning, directing and coordination of day-to-day activities of running a program or portfolio of programs. Directs the identification of risks which impact program delivery and ensure mitigation strateg...

Engages in activities to provide support to the Compliance and Operational Risk teams in order to provide independent compliance and operational risk oversight of Credit Risk performance and any related third party/vendor relationships in alignment with the Global Compliance - Enterprise Policy, the...

The Senior Associate, Regulatory Affairs is responsible for supporting applications under pre and post approval conditions. Under the direction of Regulatory Affairs management, participate in drug development from early stage development through final formulation, ensuring compliance with principle...

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...

Support the development of regulatory strategy and update strategy based upon regulatory changes. Manage the regulatory activities for multiple projects simultaneously and respond readily to changing events and priorities. Ensure timely completion, accuracy, and quality of all regulatory and submiss...

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, ...

Responsible for fabricating any tolerance fixtures or gauges needed for operational or quality usage.Maintain the cleaning of all tool room equipment and machinery used to perform job functions.Keep employees on assigned tasks and deadlines.Identify training needs and provide adequate training for c...

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...

Associate) Director, US Regulatory Affairs, Advertising & Promotion - Permanent - NJ & MA. Proclinical is seeking an (Associate) Director, Regulatory Affairs, Advertising & Promotion for a global pharmaceutical company with their location in New Jersey. The (Associate) Director, Regulatory Affairs, ...