Sr Quality Associate Regulatory Supervisor- Fsp

5 meses atrás

Lisboa, Portugal Fortrea Tempo inteiro

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
- Job Overview:

- Collaborate with peers across the organization in order to achieve client-centric delivery in a matrix organization. In particular, collaboration across all stakeholders within Site Readiness. Oversight and accountability of Regulatory Authority (RA), Independent Review Board (IRB)/Ethics Committee (EC) and Third Body submissions for designated projects within Site Readiness.
- Summary of Responsibilities:
- Oversight and accountability for RA IRB/EC and Third Body submissions, including submission strategy, timeline planning, and delivering to the agreed upon timelines by tracking submission/approval timelines against projected milestones within relevant systems. Coordinate responses to queries and ensure the required timelines are met. Provides consolidated country requirements and regular status updates to project team and Client, as applicable. May be assigned to smaller projects in terms of size and complexity in regional and/or global role.-
- Responsible for ensuring the compliance of deliverables to applicable regulations, guidance requirements and client requests by preparing, reviewing, and providing input to core study documents as applicable. This may include the compilation, review and distribution of core package, QC of core package, and country packages, maintenance and close out.-
- Provide the highest quality advice on regulatory issues to members of project teams and its clients by maintaining awareness of current regulatory legislation, guidance and practice related to RA, IRB/EC, and Third Body submissions. Evaluate the impact of clinical/regulatory changes on assigned project as well as overall business operations-
- Liaise with and/or support local teams to liaise with RA, IRB/EC, and Third Bodies on behalf of clients.-
- Review and input into required Start Up project plans. Distribute, implement, and monitor compliance to a Start Up project plan with respect to RA, IRB/EC, and Third Body submissions.- Ensure responsible deliverables are met within required timelines maintaining awareness of Green Light (GL) approval and Site Ready to Enroll (RTE) milestones. Proactively identifying and escalating to Start-up Lead any risk to meeting deliverables.- Manage projects according to the billing guide to ensure the work is performed within budget. Notify the Start-Up Lead of hours identified as Out-of-Scope or overburn.- Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met. Initiate improvements to enhance the efficiency and the quality of the submission work performed on assigned projects. Support audits (internal and external) and inspections, as needed. Support resolution of any findings.- Present/attend at external and internal meetings including, but not limited to: project core team and client meetings, Pre-Post Award Transition (PPAT) and Time Expectations Meetings (TEM), Kick Off Meetings (KOM).- Contribute to the development of the group through participating in process improvement initiatives, e.g., developing and updating SOPs.- Mentor more junior Site Readiness team members. Perform any other duties as required by the department.- All other duties as needed or assigned.

Qualifications (Minimum Required):
- Recommended: Bachelor's Degree in Life Sciences or equivalent- Fortrea_ _may_ _consider_ _relevant_ _and_ _equivalent_ _experience_ _in_ _lieu_ _of_ _educational_ _requirements._

Language Skills Required:
- Speaking: Yes, English- Writing/Reading: Yes, EnglishCompetencies:
- Information purposes only:
- Focus on Customers, Innovate and Change, Work Well with Others, Develop Self and Teams, Gets it Done

Experience (Minimum Required):
- Minimum Required:
- Minimum 3 years of experience in the Pharmaceutical/CRO industry in Regulatory Affairs or Drug Development

Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic informatio

  • Associate Principal Scientist, Regulatory

    5 meses atrás

    Lisboa, Portugal Organon Tempo inteiro

    Reporting to the Established Brands Dermatology Portfolio lead in our Company's Regulatory Chemistry, Manufacturing & Controls (CMC), the Associate Principal Scientist is responsible for developing and implementing Regulatory CMC strategies for assigned small molecule or biological products in accordance with global regulations and guidance's, and Company...

  • Sr / Regulatory Medical Writer - Certain Emea

    5 meses atrás

    Lisboa, Portugal Thermo Fisher Scientific Tempo inteiro

    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...

  • Sr / Regulatory Medical Writer - Certain Emea

    5 meses atrás

    Lisboa, Portugal Thermo Fisher Scientific Tempo inteiro

    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...

  • Sr Associate Treasury

    Há 6 horas

    Lisboa, Portugal Amgen Tempo inteiro

    **SR ASSOCIATE TREASURY - CASH MANAGEMENT** **LIVE** **WHAT YOU WILL DO** As our Sr Associate Treasury, will manage cash management operations and ensure that the daily Treasury transactions are processed smoothly. We have a diverse team and are looking for an enthusiastic colleague who is eager to succeed and fits well in our...

  • Senior Associate Regulatory Affairs

    2 meses atrás

    Lisboa, Portugal Tampa Gardens Senior Living Tempo inteiro

    Global Regulatory Affairs Manager · We're currently seeking a Global Reg Affairs Manager for an award-winning pharma company specialising in OTC products. Overseeing the whole dossier process, working with license variations, acting as a submission specialist will all be core com ...In the context of our growing activities, we are looking for a Regulatory...

  • Associate Principal Scientist, Regulatory

    5 meses atrás

    Lisboa, Portugal Organon Tempo inteiro

    **The Position** The Associate Principal Scientist is responsible for developing and implementing Regulatory CMC strategies for assigned small molecule products in accordance with global regulations and guidance's, and Company procedures. The Associate Principal Scientist will lead the preparation and submission of CMC dossiers for life-cycle maintenance...

  • Study Start Up Associate

    Há 2 dias

    Lisboa, Portugal ICON Plc Tempo inteiro

    Study Start Up Associate II - Fluent Dutch Required ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development Study Start Up Associate / Regulatory...

  • Regulatory Affairs Chemistry Manufacturing Associate Director

    3 semanas atrás

    Lisboa, Lisboa, Portugal Organón Tempo inteiro

    Job Title: Associate Principal Scientist, Regulatory Affairs Chemistry ManufacturingJob Summary:The Associate Principal Scientist, Regulatory Affairs Chemistry Manufacturing will provide regulatory CMC support for Organon Network Projects. This position will lead the preparation and submission of CMC dossiers for assigned Network Projects. The individual may...

  • Senior Clinical Research Associate

    3 meses atrás

    Lisboa, Portugal TFS HealthScience Tempo inteiro

    TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions. **Join Our Team as a** **Senior Clinical Research...

  • Sr. Associate Accountant

    5 meses atrás

    Lisboa, Portugal Amgen Tempo inteiro

    **HOW MIGHT YOU DEFY IMAGINATION?** **The Amgen Capability Center in Lisbon, Portugal (ACCP)** will be home to over 300 multi-national and multi-cultural employees, representing a broad range of cross-functional capabilities, including Commercial, General and Administrative, Research and Development, and more. The ACCP will offer rich career growth and...

  • Clinical Research Associate

    3 semanas atrás

    Lisboa, Lisboa, Portugal Tfs Healthscience Tempo inteiro

    TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey.Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.About the RoleAs a Clinical Research Associate, you will be working...

  • Regulatory and Start Up Specialist

    5 meses atrás

    Lisboa, Portugal Novasyte Tempo inteiro

    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. Fluent in both Portuguese and English. At least 1 years'...

  • Associate Principal Scientist Regulatory Affairs Chemistry Manufacturing

    3 semanas atrás

    Lisboa, Lisboa, Portugal Organón Tempo inteiro

    Job Title: Associate Principal Scientist, Regulatory Affairs Chemistry ManufacturingThe position of Associate Principal Scientist, Regulatory Affairs Chemistry Manufacturing, is a key role within Organon's Chemistry, Manufacturing & Controls (CMC) team. This individual will provide regulatory CMC support for Organon Network Projects, leading the preparation...

  • Clinical Research Associate

    4 semanas atrás

    Lisboa, Portugal TFS HealthScience Tempo inteiro

    **TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.** **Join Our Team as a** **Clinical Research Associate...

  • Sr HR Analyst

    5 meses atrás

    Lisboa, Portugal Amgen Tempo inteiro

    **Sr HR Analyst - Compensation/Benefits** **LIVE** **What you will do** Amgen is seeking a Senior Associate Human Resources (HR) - Systems and Solutions who will provide overall support for Amgen’s Workday system with a focus on the Core Compensation and Advanced Compensation modules. The Sr. Associate HR will contribute to the delivery of high quality...

  • Regulatory Compliance Specialist

    Há 12 horas

    Lisboa, Lisboa, Portugal Hovione Tempo inteiro

    About the RoleHovione is a global contract development and manufacturing company seeking a highly skilled Quality Systems Associate to join our team.This key position will be responsible for implementing and managing quality systems and guidelines, ensuring compliance with cGMPs and regulatory requirements.We are looking for a candidate with a strong...

  • Associate Principal Scientist, Regulatory Affairs Chemistry Manufacturing

    3 semanas atrás

    Lisboa, Lisboa, Portugal Organon Tempo inteiro

    Job Title: Associate Principal Scientist, Regulatory Affairs Chemistry ManufacturingOrganon is seeking a highly skilled Associate Principal Scientist to join our Regulatory Affairs Chemistry Manufacturing team. As a key member of our team, you will be responsible for providing regulatory CMC support for Organon Network Projects.Key Responsibilities:Lead the...

  • Sr HR Analyst

    5 meses atrás

    Lisboa, Portugal Amgen Tempo inteiro

    **S**r HR Analyst - Time & Absence** **LIVE** **What you will do** Amgen is seeking a Senior Associate Human Resources (HR) - Systems and Solutions who will provide overall support for Amgen’s Workday system with a focus on the Time and Absence modules. The Sr. Associate HR will contribute to the delivery of high quality and timely service to...

  • Senior Associate Regulatory Affairs

    3 meses atrás

    Lisboa, Portugal Cloverland Park Senior Living Tempo inteiro

    Senior Associate Regulatory Affairs (1-year fixed-term contract) in Lisbon , Portugal HOW MIGHT YOU DEFY IMAGINATION?THE AMGEN CAPABILITY CENTER IN LISBON, PORTUGAL (ACCP ) will be home to over 300 multi-national and multi-cultural employees, representing a broad range of cross-functional capabilities, including Commercial, General and Administrative,...

  • Credit Risk

    5 meses atrás

    Lisboa, Portugal BNP Paribas Tempo inteiro

    CREDIT RISK - REGULATORY REPORTING SUPERVISOR (JOB NUMBER: 2311GFSO16590) **About the job** - The Credit Risk - Regulatory Reporting Supervisor with his team contributes to the Credit Risk RWA computation and analysis, contributing to the calculation of the Group Basel solvency ratio and Pillar 3 disclosures (includes Group Accounting to Risk...