Senior Regulatory Affairs Associate. Assessment of the Change Controls and associated technical dossiers. ...
The Associate Director, Regulatory Affairs will be responsible for supporting the development and implementation of global Chemistry, Manufacturing and Control (CMC) regulatory strategies and managing the preparation of supporting documents. This individual will support the CMC Team and provide dire...
Previous CRO / Pharma experience working in the capacity of a Regulatory Affairs Consultant or Senior Regulatory Affairs Consultant with CTA submission knowledge is essential, knowledge in MAP and NIS would be a plus. We are recruiting for a French Speaking Senior Regulatory Affairs Associate in Eur...
As Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC) Manager, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously. Drives the CMC s...
As a Senior Regulatory Affairs Associate you will come with a few years of Regulatory Affairs experience gained in the industry. ...
The Associate Director will be accountable to the GRL and Global Regulatory Science Precision Medicine Head for development of appropriate regional Precision Medicine and Digital Health regulatory strategy(s) and their timely delivery. This goal must be achieved both as a component of an overall glo...
The Regulatory Affairs Associate will support regulatory requirements for a wide range of drug product types, ensuring compliance with global regulatory standards. We are hiring an experienced Regulatory Affairs Associate to join our team in York, PA – remote work is permitted. PSC Biotech provides ...
Manage portfolio timelines in collaboration with Regulatory Operations and Regulatory Affairs staff to effectively enable a robust regulatory submissions calendar. Review clinical site regulatory documents to provide Regulatory approval to ship investigational product. Assist Project Team Regulatory...
The Regulatory Affairs Associate will support regulatory requirements for a wide range of drug product types, ensuring compliance with global regulatory standards. We are hiring an experienced Regulatory Affairs Associate to join our team in York, PA – remote work is permitted. PSC Biotech provides ...
The Regulatory Affairs Associate will support regulatory requirements for a wide range of drug product types, ensuring compliance with global regulatory standards. We are hiring an experienced Regulatory Affairs Associate to join our team in York, PA – remote work is permitted. PSC Biotech provides ...
This includes assessing CMC changes during development and defining regulatory CMC requirements, demonstrating sound regulatory insight, ensuring a balanced approach to regulatory risk, utilizing regulatory intelligence, and incorporating knowledge of the changing regulatory environment. Reporting t...
The Regulatory Affairs Associate will support regulatory requirements for a wide range of drug product types, ensuring compliance with global regulatory standards. We are hiring an experienced Regulatory Affairs Associate to join our team in York, PA – remote work is permitted. PSC Biotech provides ...
Director of Regulatory Affairs, Academic Affairs Office, Penn Law. Director of Regulatory Affairs, Academic Affairs Office, Penn Law. The Director of Regulatory Affairs serves as the point person for all regulatory issues related to the University of Pennsylvania Carey Law School's program of educat...
The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for Philips' Disease Management Solution products, ensuring and maintaining global accurate regulatory strategy and market access, directly impacting the l...
The Regulatory Director may be the single point of contact on assigned asset(s), responsible for regional and global regulatory strategy(ies). This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and w...
The Principal Regulatory Affairs Specialist will play a critical role in preparing comprehensive regulatory strategies for complex new devices and post market changes within Philips' Ultrasound business. Develop regulatory strategies and communicate risks within regulatory strategies vs project plan...
Experience in clinical regulatory affairs as well as CMC regulatory affairs for pre-licensed and licensed biologic product or vaccine. Understand the constraints and drivers of other functions and the potential impact on regulatory affairs World-wide, including how regulatory affairs may facilitate ...
The Senior Regulatory Affairs Program Manager will play a critical role in ensuring Philips' Ambulatory Monitoring & Diagnostics (AM&D) products are compliant by preparing comprehensive global regulatory strategies for new devices and significant post market changes. Regulatory Affairs Program Manag...
Senior Regulatory Affairs Specialist. Responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regulatory approval, preparing US and EU submissions, and ensuring timely and high-quality execution of all regulatory deliverables. Serve as RA Repre...
Responsible for managing projects, programs with multiple integrated projects, or portfolios of related projects including defining, planning, and ensuring execution of all tasks necessary to meet project/program/portfolio objectives. Looking for a lifetime career? Apply today!Job DescriptionJoin th...
Mortgage Quality Control and Compliance Analyst. Performs detailed residential underwriting and compliance analysis on loans in-process and post-closing for credit, compliance and documentation deficiencies and determines marketability of each loan. This position will be responsible for performing c...
Oversees submission of regulatory documentation and informed consent documents for the Scientific Review Committee (SRC) and the Institutional Review Board (IRB) and follows-up with investigators to ensure compliance with all policies and regulations. Oversees submission of regulatory documentation ...
RES is looking for a Regulatory Specialist with at least 1 year of experience for our Pittsburgh Office. ...
The Senior Project Manager is responsible for overall management of clients and projects including design, communications, personnel management, budgets, schedules, quality control, business development, and client communication & relationships. The Senior Project Manager manages services o...
As a Regulatory Affairs Specialist, you will play a crucial role in connecting companies, their products, and regulatory authorities. The Regulatory Affairs Specialist is directly responsible for the preparation, organization, compilation, and ongoing maintenance of the regulatory dossiers. We are l...