SENIOR REGULATORY OPERATIONS MANAGER - BARCELONA, SPAIN
Descripción de la oferta de empleo
We provide customized Phase I through IV services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases.
Position Overview The Senior Regulatory Operations Manager works closely with Regulatory Operations Department Management assuming a leadership role in the research, development.
Specific tasks would include.
Act as Regulatory Country Expert and compiles submission packages and dossiers and reviews all documents required for submissions to ECs (ex-US), and Regulatory Authorities.
Serves as interface between regulatory authorities, ECs (ex-US) and the Regulatory Lead Ensures that clinical trials applications (CTAs) are conducted according to local/international requirements/procedures (e.
., ICH-GCP and applicable local law, guidelines, and internal procedures).
Prepares National Informed Consent Forms, and performs lay language review Ensures compliance with Regulatory Agency rules and guidelines pertaining to regulatory submissions (paper and electronic).
Anticipates areas with the potential to jeopardize regulatory timelines and identifies solutions.
Assists in the management of established timelines to achieve client deliverables on time/within budget.
Attends project team meetings, if needed.
Assists the pharmacovigilance team with safety reporting, if required May serve also as Regulatory Lead for multinational clinical trials and coordinates submissions for those projects As regulatory lead be the primary regulatory contact for clients Is responsible for managing regulatory timelines and resources for the studies assigned to achieve client deliverables on time and within budget.
Contributes to the company's Regulatory Intelligence database and supports the Regulatory Intelligence Officer, as needed.
Helps prepare for, and participates in, client and regulatory authority audits and inspections.
May perform QC review of any regulatory / submission documents.
Supports business development in preparing and defending requests for proposals.
Reviews, revises, and writes department procedures, as needed Serves as Regulatory Lead for larger, complex, global clinical trials without acting as Regulatory Country Expert and performing associated national submissions Assumes a leadership role in the regulatory operations department, guides regulatory operations team members and acts a role model for department members Qualifications Bachelor's degree in business, life sciences or related field of study and 8+ years Regulatory Operations experience in the pharmaceutical industry / Clinical Research Organization, or equivalent combination of studies and relevant work experience inclusive of substantial experience in researching, reviewing, and processing regulated documents and the demonstrated ability to provide guidance and direction to others effectively Advanced knowledge base of global regulation of investigational and marketed medicinal products including international and national regulations and guidelines, depending on regional responsibility (e.
European, US and Canadian regulations/guidelines).
Ability to evaluate regulations and electronic processes and requirements.
Proficiency in Microsoft Word, MS Project, Excel, and PowerPoint, Outlook.
Highly effective verbal and writing skills; English + knowledge of local language is mandatory for submissions/correspondence with authorities and Ethics Committees.
Proficiency in secondary language desirable.
If you're passionate about clinical trials, we encourage you to apply today! Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, colour, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category.
Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire.
The Company will not sponsor applicants [to this position] for work visas.
We are searching for a french speaking call center operations manager who has a passion for people... assist the contact center manager with the compliance and reporting for all call center operations including call volume forecasting and staffing, client service commitments, budgeting and p&l;, service......
Description: international company is looking for project controls manager... strong understanding of project management and proven senior management skills... 8 years' experience (for large contracts) on project controls or as project engineer or project manager... assists pro-actively the project manager......
Años project manager/engineer manager/project engineer; experiencia como engineer manager / project manager... description: international company is looking for project manager... inglés (mandatorio) + frances (valorable) + aleman (valorable)... functions: gestión de proyecto, coordinación de equipo......
Proven senior management skills... description: sr contract manager with 10+ years' experience in the related field... assists pm and/or site construction manager in the preparation and negotiation of the changes to the contract baseline as well as resolution of constructive contract changes with respect......
We are hiring an interested customer operations manager who is looking for the right and legit way to supplement your earnings while working from home... high school diploma or equivalent !... basic english spoken language... this position is opened to a full-time, part-time role and work remotely in......
¿tienes experiencia como jefe de operaciones? ¿tienes espíritu comercial y con motivación por nuevos retos? ¿te gustaría formar parte de una empresa estable en el sector? por favor, ¡sigue leyendo! mst holding, especialistas en el sector de contact center y consultoría, con la tecnología más innovadora......
Mantenerse al día con las tendencias y la tecnología en diseño ux/ui y front-end... persona proactivia, responsable y resolutiva, acostumbrada a trabajar en equipo... ¿te sumas a un proyecto de crecimiento internacional del sector moda de alta costura? el departamento de it en la sede headquarters en......
Aveva engineering, deseable (ms office)... analizará los requerimientos del cliente relacionados con los datos (calidad, formato, consistencia)... funciones: garantizará el control y calidad de la información digital de proyecto y del hand-over al cliente... descripción: empresa internacional del sector......
Empresa de telecomunicaciones (másmovil) con más de 10 años en el sector busca comercial para mantenimiento de cartera de clientes y expansión de la zona asiganda... imprescindible disponer de vehículo propio... conocimientos de excel... requisitos del puesto 2 años de experiencia en el sector de las......
In addition, the operations executive will take responsibility for certain office management duties as indicated by the operations manager of the group... in this role, the operations executive will support the operations manager in the administration of group functions as they relate to the group......