Ver oferta completa


Descripción de la oferta de empleo

Europe RA CMC Specialist|4 days/week home officeInternational biotechnology group committed to developing innovative therapies for the treatment and prevention of allergies.
Prepare, compile and review regulatory submissions for the medicinal products for European and non-European territories in line with regional and local requirements and scientific and company policies and procedures, requiring interactions with departments outside of RA
Prepare and review high quality CMC documents and/or packaging components for assigned regulatory submissions to ensure that documents are produced in compliance with the applicable regulatory requirements
Provide regulatory guidance, advice and input into regulatory submission strategies for products in established and new markets
Review packaging components, artworks and promotional materials in collaboration with Production and Commercial team
Effectively prepare safety variations including the review of SmPCs and subsequent updates to PILs
Representative on the company projects. Act as a point of contact for stakeholders, customers and project team members for the advancement of assigned projects and for the maintenance of regulatory quality of assigned projects, and to resolve questions and issues related to these products
Perform assessment of RA-CMC information for assigned projects and define strategies that reduce drug development and registration timelines
Active involvement in concepts/projects from Regulatory Strategy to meet project needs
Prepare and review change control proposals, regulatory impact and risk assessments as appropriate
Ensure regulatory trackers are updated and maintained in a timely manner
Maintain accurate and complete paper and electronic files according to applicable procedures
Communicate with regulatory agencies and document communication
Initiate or contribute to local process improvements which have an impact on the working of the RA function and/or other departments
Prepare, update and review Regulatory global and local SOPs
Train new employees in regulatory compliance of current guidelines and legal aspects where required
Provide RA support to local and global departments.
Assist in the preparation, review, maintenance and submission of the required facility/company licenses/authorizations.
Provide regulatory support for external audits or inspections
Barcelona Based
4 days Home Office 1 day Office
International team
Fix contract
Social benefits
Good environment and great team
Ver oferta completa

Detalles de la oferta

  • Michael Page
  • Sin especificar - Sin especificar
Tipo de Contrato
  • Sin especificar
Fecha de publicación
  • 30/05/2022
Fecha de expiración
  • 28/08/2022
English-speaking Junior Treasury Specialist in Barcelona
City Job Offers

International environment with a young and dynamic team... if you are excited to be part of an international company, apply for this job opportunity as a treasury specialist in barcelona!... english-speaking junior treasury specialist for the financial department we are looking for a reliable treasury......

English-speaking Procurement Specialist in Barcelona
City Job Offers

International environment with a young and dynamic team... if you are excited to be part of an international company, apply for this job opportunity as a procurement specialist in barcelona!... english-speaking procurement specialist in barcelona are you an oriented-goal individual? do you have financial......

German Sales Representative Specialist in Barcelona
City Job Offers

German sales representative specialist in barcelona with relocation come to barcelona with great conditions + relocation package and start your international career... german-speaking sales representative specialist we have an exciting job opportunity for german speakers who want to live in barcelona......

Recruitment Specialist / Headhunter (freelance)

Years experience as internal recruiter (across the entire recruitment process) within an international company; strong expertise in direct search and in recruiting via social media (linkedin, mainly); english (2nd language is a plus!) business acumen; creating and reporting hr kpis related to recruitment......

Health and Safety Specialist
Telus International

Perform regular risk assessment and report the results to the hr and local management make conclusive proposals for control and preventive measures derived from risk assessments planning of the preventive activities and direct the actions to be developed create emergency plans and simulations management......

Specialist Technician Nanomedicine Group

The specialist technician would be expected to undergo full training in all techniques and protocols to be used, and thereafter to perform the experiments with minimal supervision... requisitos del puesto education: degree in chemistry, chemical engineering, materials science, biochemistry, or equivalent......

Collections Specialist with a Native Level of German
Talent search people

We are looking for a collections specialist with a native level of german and fluent in english based in barcelona... experience as a collections specialist would be a plusotros datos del puesto- an environment where diversity is essential, inclusion is our culture, and each person knows they belong......

Seo specialist
Carlos losada viejo

Estamos buscando para una agencia de marketing que trabaja con multinacionales un seo specialist para incorporarse al equipo de barcelona... estrategia de linkbuilding... ) investigación de palabras claves (google adwords keyword planner y otras herramientas) adaptar las estrategias de keywords y de......

Project Specialist

Coordinación entre cliente y agencia y control sobre los recursos y personas asignadas al proyecto... skills: trabajo en equipo, motivación, dotes de comunicación, influencia, proactividad en la toma de decisiones, conocimientos de política y cultura de agencia y cliente, capacidad de negociación, generar......

Specialist Technician

Job title: specialist technician research area or group: nanobiosensors and bioanalytical applications group description of group/project: nanob2a group focuses on the development of novel nanobiosensor devices based on plasmonics, nanoplasmonics and silicon-based photonics principles, including surface......