Trabajos regulatory manager en Elizabeth, New Jersey (NJ) State

The individual combines knowledge of scientific, regulatory, and business processes to properly drive the execution of Innovent’s regulatory strategies. Formatting the regulatory documents according to the regulatory agency guidelines. Global Regulatory Affairs Operation（Sr. This position belongs...

My client is a multinational CDMO looking for a Regulatory Affairs Manager to work with the FDA and their client sites to manufacture generic APIs, drug products, and certain med devices. Experienced with the preparation and submission of regulatory documents, including PIND meeting packages, IND...

Manager of Regulatory Affairs Strategy to join their team. Serves as a liaison to FDA and provides strategic input with the regional regulatory leads responsible for ex-US regulatory activities. We are currently partnered with a growing biopharmaceutical company in need of a Manager/Sr. This role...

We have an exciting opportunity for a Project Manager, Litigation Support, Enforcement:The Project Manager, Litigation Support will provide investigation, technical, and e-discovery support for Enforcement reviews and investigations, and specialized litigation support to Enforcement litigation st...

JCW is currently recruiting on behalf of a leading investment bank that's looking to hire an Audit Manager for their growing Regulatory Remediation group. As part of a team focused solely on managing the regulatory requests and remediation efforts of the bank, this role will have ample visibility...

We are seeking a highly organized and detail-oriented individual to join our team as a Manager, Submissions Publishing. In this role, you will be responsible for overseeing the regulatory submissions publishing process, ensuring compliance with industry standards and timelines. You have a thoroug...

The person will be responsible for the creation and maintenance of regulatory CMC documents in the controlled document management repository. Work cross functionally to coordinate the preparation of draft responses to technical regulatory questions from health authorities including writing of exp...

The Regulatory Change Manager is responsible for monitoring regulatory change across applicable issuing bodies and working with appropriate stakeholders to adapt policies, standards, and controls to applicable regulations ensuring continuous compliance. Monitor upcoming, in development and releva...

In this role, the CMC Regulatory Manager will serve as the primary interface between Global Regulatory Sciences (GRS) & Global Product Supply (GPS) The GRS-CMC senior manager will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change ...

Project Manager with BASEL Regulatory. Project Manager, BASEL, Regulatory, Agile. Solid background and - years of experience in Client regulatory/ risk reporting projects. ...

The Pharmaceutical Regulatory Affairs Senior Manager will use their experience and knowledge in pharmaceutical industry regulatory affairs to lead and manage complex projects for our clients in the pharmaceutical sector, and provide strategic advice, guidance, and solutions on regulatory matters....

The Regulatory Change Manager is responsible for monitoring regulatory change across applicable issuing bodies and working with appropriate stakeholders to adapt policies, standards, and controls to applicable regulations ensuring continuous compliance. Monitor upcoming, in development and releva...

SummaryA career in our Balance Sheet Management practice, within Financial Risk and Regulatory services, will provide you with the opportunity to help business leaders embed a proactive and dynamic risk management capability and mind set into their corporate business practices. You’ll help build ...

The Manager of Internal Audit Regulatory Issues Management position is a a managerial role within the Internal Audit's regulatory exam and issues management function. The Audit Manager position is a managerial role supporting the maintenance and operations of the regulatory relationship with US P...

Technical Program Manager will be responsible for leading the management and execution of server platform programs compliance testing throughout the product lifecycle, scoping required compliance testing from product specification definition, and feature scoping through production release and end...

SummaryA career in our Balance Sheet Management practice, within Financial Risk and Regulatory services, will provide you with the opportunity to help business leaders embed a proactive and dynamic risk management capability and mind set into their corporate business practices. You’ll help build ...

The Senior Manager of Internal Audit Regulatory Issues Management COE is a self-starter who exudes energy, curiosity, and enthusiasm to take on a managerial role within Internal Audit's regulatory exam and issues management function. Manages activities through senior managers and managers and imp...

Responsibilities Actively contribute to the development of regulatory strategies for investigational products in Investigational New Drug (IND)/ Clinical Trial Applications (CTA), Biologics Licensing Application (BLAs)/ Marketing Authorization Application (MAA), through evaluating scientific meri...

Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams. Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. These submissions include health authority briefing packages, IND/CTA,...

Our Tax Controversy and Regulatory Services team helps our clients navigate the Internal Revenue Service process to facilitate compliance, drive issue resolution, and assist with strategic forward planning. As a Senior Manager, you'll work as part of a team of problem solvers, helping to solve co...

Job Description: Medical Cell Therapy Onboarding Manager. The Field Medical Cell Therapy Onboarding Manager is a member of a field-based team of scientists who function as an extension of the US Hematology Medical Affairs organization. The CT Onboarding Manager is responsible for verifying medica...

As the Senior Manager, Regulatory Affairs you will be responsible for the development and execution of US regulatory strategy for projects within an assigned Therapeutic Area (“TA”). Develop and execute US regulatory strategy, with oversight as needed, and in conjunction with Global Regulatory Le...

Lead regulatory affairs activities, including the preparation of regulatory submissions and interactions with regulatory authorities. We are seeking a highly motivated and experienced Quality Assurance & Regulatory Affairs Manager to join our dynamic team. This is an exciting opportunity for a se...

Deloitte Risk and Financial Advisory's Financial Services Industry (FSI) Risk, Data and Regulatory professionals help organizations identify the regulatory changes impacting their business and implement effective and efficient processes to manage regulatory, capital, liquidity and interest rate r...