Regulatory Affairs Manager

**Summarized Purpose**: Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local,...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office In this role as a Sr Regulatory Affairs Specialist, you will be part of our Regulatory Liaison team, leading on communications with regulatory agencies as part of centralized regulatory submissions including but not limited to the EU CTR process. You will partner with our Regulatory...

In the context of a new project, we are looking for a Regulatory Affairs Associate to join our teams in Mexico. **Responsibilities**: Assisting with the preparation of LATAM Marketing Authorization Applications Preparation and submission of documentation for post-authorization activities Compile Dossier as per country requirements Education &...

We are currently seeking a Senior Regulatory Affairs Specialist to join our global Regulatory Affairs department. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting. In this role you will be a pivotal team member with regulatory affairs responsibilities, leading discussions, and...

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office The following skills are required to be successful in this position: - preparation and assembly of global regulatory submissions - interacting with sponsors, - review and assess clinical trial regulatory documents, - review and assess scientific literature. - manages project teams...

Supports the preparation of documentation and submissions under guidance - Coordinates and manages client deliverables supporting regulatory compliance - Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects - Assists with project budgeting/forecasting - Maintains knowledge and...

**BASIC FUNCTIONS**: The Associate Feasibility Manager is responsible for supporting the coordination and management of the efforts necessary for producing feasibility proposals and reports. In this capacity, this individual is responsible for assuring the Feasibility Associates and Analysts elicit input from and coordinate activities with all the stake...

Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Essential Functions - Under general supervision, serve as...

Summarized Purpose: Provides advanced administrative support to the department and supports reporting of such to upper management. Essential Functions - Track each regulatory submission in required tracker system (PPD or sponsor), (Veeva, eTMF, Activate, CTMS). - Review Sharepoint to ensure correct regulatory information is captured as per the tracked...

Conduct complex internal and external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines, and client contractual obligations. Identify issues impacting the quality and/or integrity of clinical research programs, determine root cause of non-conformance and develops strategies to address...

**¡Sé parte de Stefanini!** En Stefanini somos más de 30.000 genios, conectados desde 40 países, haciendo lo que les apasiona y co-creando un futuro mejor. ¡Seguro no te quieres quedar fuera! **PROJECT MANAGER** **Responsabilidades y atribuciones** **Responsibilities**: - Manage several concurrent projects successfully - Manage project deliverables...

**(Senior) Project Manager/Lead (Delivery)** At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career...

- Requirements: - 5+ years of experience as a Project Manager focusing on software data projects using Agile Scrum methodology. - 3+ years of experience with data projects as a Project Manager. - Strong understanding of Agile Scrum principles, practices, and ceremonies, with experience leading teams through the entire software development life cycle...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Project Lead/Manager (Delivery)** At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide...

Job Overview Essential Functions - Oversee the work of assigned site management staff, providing advice and guidance to help achieve quality deliverables on site. - Assist with the development of Site Recruitment, SPS Operations and SPS Risk Management Plans. - Ensure that clinical monitoring tasks are conducted in accordance with protocol, process, quality...

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Summarized Purpose**: Provides moderate, expedient, and efficient preparation of client electronic submission deliverables and dossier that meet current local, regional and ICH regulatory and technical requirements. Ensures successful regulatory review outcomes for product...

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

Job Overview Under moderate supervision, executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level. Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites and sponsors;...