Sr Regulatory Affairs New
hace 2 meses
Location:
Madrid, Spain
- Contact:
Susagna Sastre Magem
- Job type:
Temp to Perm
- Industry:
Pharmaceutical, Life Sciences, Biotechnology
Oxford Global Resources ETT is looking to hire a **Regulatory Affairs Specialist (maternity leave) who will start in August 2023**. As a Regulatory Affairs Technician you will support a top leading research-based bio pharmaceutical company focused on the discovery, development, and commercialization of innovative medicines.
**Responsibilities**:
- ** Review promotional and non-promotional materials in accordance with the company internal promotional guidelines, national regulations and Codes of Practice. Provision of guidance and assistance to Marketing during preparation of promotional material.**:
- Cross functional interactions with Business Unit, Medical and other departments if required. Provision of regulatory advice as appropriate
- Translation of Regulatory documents. Submission and follow-up of regulatory submissions to national authority as well as the amendments to product information as required by acting as a Liaison with Int RA for these activities.
- ** Submission of clinical trials amendments and notifications to competent authorities of the clinical trials under his/her responsibility**:
- ** Regulatory Intelligence: Competitors, new regulations or other relevant information**:
- Quality topics: Knowledge of applicable regulations. Preparation and update of Quality SOPs, management of complaints and other quality topics.
- Creation and update of SOPs and associated process documentation as required.
**Education**
- Bachelor's degree (or equivalent) in a scientific discipline.
- Minimum of 2-3 years (in CRO or Pharma) working in Spain regulatory affairs is required
- Experience in initial CTA is essential
- Hands-on experience preparing, reviewing, and submitting regulatory documentations
**Benefits**
- Interim/temporary contract maternity leave
- Ticket Restaurant
- Medical Insurance
- Hybrid 60% home-based
-
Regulatory Affairs Intern
hace 1 mes
Madrid, España Kenvue A tiempo completo**Regulatory Affairs Intern**-2307004145W Description Cooperation with Commercial/Marketing teams. **Medicines Regulatory activities**: - New marketing authorization activities - Maintenance activities of existing licenses: preparations of administrative, quality regulatory packages and safety related variations for their submission to Healthcare...
-
Regulatory Affairs Technician
hace 1 mes
Madrid, España ABBVIE A tiempo completo**Overall responsibilities** To provide regulatory advice and support to the organization on the content of existing marketing authorizations and for products in development phase. Support pharmacovigilance department on safety relevant matters in line with national requirements **Main Accountabilities** - Obtain marketing authorizations for new...
-
Regulatory Affairs Manager Emea/apac
hace 3 días
Madrid, España Blu Selection A tiempo completoOur client is looking for a dynamic and experienced Manager of Regulatory Affairs and Compliance to oversee the Regulatory Affairs functions for the EMEA and APAC regions. **Your Responsibilities and Impact as Regulatory Affairs Manager will be**: - Supervising Regulatory Affairs for EMEA and APAC jurisdictions, ensuring adherence to procedures and...
-
Regulatory Affairs Product Development
hace 3 días
Madrid, España Morgan Philips Executive Search A tiempo completo**Global responsibility**: Provide regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. Coordinates and...
-
Regulatory Affairs Specialist
hace 2 semanas
Madrid, Madrid, España Sealed Air Corporation A tiempo completoSEE designs and delivers packaging solutions that protect essential goods transported worldwide, preserve food, enable e-commerce and digital connectivity, and help create a global supply chain that is touchless, safer, less wasteful, and more resilient. Our people are entrepreneurial innovators and problem solvers committed to bringing unique insights and...
-
Regulatory Affairs Specialist
hace 1 semana
Madrid, Madrid, España Sealed Air Corporation A tiempo completoSEE designs and delivers packaging solutions that protect essential goods transported worldwide, preserve food, enable e-commerce and digital connectivity, and help create a global supply chain that is touchless, safer, less wasteful, and more resilient. Our people are entrepreneurial innovators and problem solvers committed to bringing unique insights and...
-
Regulatory Affairs Specialist
hace 2 semanas
Madrid, España Zentiva Group, a.s. A tiempo completoMission The Regulatory Affairs Specialist at local/country level is accountable for managing the Regulatory Affairs agenda at country level within Zentiva. This will include: Provide an efficient and proactive Regulatory service to meet the business objectives Support proactively commercialisation of products Ensure agility in daily interaction...
-
Regulatory Affairs Specialist
hace 2 semanas
Madrid, España Zentiva Group A tiempo completoMissionThe Regulatory Affairs Specialist at local/country level is accountable for managing the Regulatory Affairs agenda at country level within Zentiva. This will include:Provide an efficient and proactive Regulatory service to meet the business objectivesSupport proactively commercialisation of productsEnsure agility in daily interaction with authorities...
-
Regulatory Affairs Specialist
hace 1 semana
Madrid, España Zentiva Group A tiempo completoMissionThe Regulatory Affairs Specialist at local/country level is accountable for managing the Regulatory Affairs agenda at country level within Zentiva. This will include:Provide an efficient and proactive Regulatory service to meet the business objectivesSupport proactively commercialisation of productsEnsure agility in daily interaction with authorities...
-
Regulatory Affairs Specialist
hace 1 semana
Madrid, España Zentiva Group, a.s. A tiempo completoMission The Regulatory Affairs Specialist at local/country level is accountable for managing the Regulatory Affairs agenda at country level within Zentiva. This will include: Provide an efficient and proactive Regulatory service to meet the business objectives Support proactively commercialisation of products Ensure agility in daily interaction...
-
Regulatory Affairs Trainee
hace 2 semanas
Madrid, España BD A tiempo completo**Job Description Summary**: As Regulatory Affairs Trainee you will develop yourself in supporting the activities of the EMEA (Europe, Middle East and Africa) Regulatory Affairs team. The activities are related with the execution of regulatory processes of products related with Surgery, Urology and Critical Care, and Peripheral Intervention business units as...
-
Regulatory Affairs Professional
hace 2 meses
Madrid, España Parexel A tiempo completoMadrid, Spain **Job ID** R0000013557 **Category** Regulatory / Consulting **ABOUT THIS ROLE**: We are recruiting for experienced Regulatory Affairs Professionals on various levels. In this role, you will focus on clinical trial submissions. We are looking for someone who is experienced in CTA, EU-CTR knowledge and experience would be a strong plus. The...
-
Regulatory Affairs Professional
hace 1 mes
Madrid, España Parexel A tiempo completoWe are recruiting for experienced Regulatory Affairs Professionals on various levels. In this role, you will focus on clinical trial submissions. We are looking for someone who is experienced in CTA, EU-CTR knowledge and experience would be a strong plus. The role can be based in our office in Madrid or remote. **Key Deliverables in the role**: - Manage...
-
Regulatory Affairs Technician New
hace 1 mes
Madrid, España Oxford Global Resources A tiempo completoLocation: Madrid, Spain - Contact: Susagna Sastre Magem - Job type: Permanent - Contact phone: +34 935 222 338 - Industry: Pharmaceutical, Life Sciences, Biotechnology Oxford Global Resources en colaboración con Laboratorio Farmacéutico Español con fabricación y presencia y distribución internacional busca un Regulatory Affairs Officer para sus...
-
Regulatory Affairs Technician-cmc
hace 7 días
Madrid, España NonStop Consulting A tiempo completoTengo una nueva vacante como Regulatory Affairs Technician para trabajar en CMC para una importante empresa farmaceutica, el puesto es indefinido y hay muy buen ambiente laboral, ademas ofrecen muchas oportunidades de promocion. La vacante es office based con un dia de teletrabajo a la semana y el horario es flexible. **Requisitos**: 3 años de experiência...
-
Public Affairs and Regulatory Manager Spain
hace 10 horas
Madrid, España Statkraft A tiempo completoPublic Affairs and Regulatory Manager Spain - Full-time **Company Description**: Statkraft has been making clean energy possible for over a century. Today, we are Europe’s largest renewable energy producer and a global energy market operator. We are a vibrant, diverse and strongly connected community of over 4800 people, working across 19 countries within...
-
Internship Regulatory Affairs
hace 4 semanas
Madrid, Madrid, España Johnson & Johnson A tiempo completoJohnson & Johnson is currently seeking a Regulatory Affairs intern to join our Regulatory Affairs department located in Madrid. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive,...
-
Internship Regulatory Affairs
hace 1 semana
Madrid, Madrid, España Johnson & Johnson A tiempo completoJohnson & Johnson is currently seeking a Regulatory Affairs intern to join our Regulatory Affairs department located in Madrid. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive,...
-
Regulatory Affairs Technician-solidos-top Pharma
hace 2 meses
Madrid, España NonStop Consulting A tiempo completoTengo una nueva vacante como Regulatory Affairs Technician (solidos) para una importante empresa farmaceutica, el puesto es indefinido y hay muy buen ambiente laboral, ademas ofrecen muchas oportunidades de promocion. La vacante es office based con un dia de teletrabajo a la semana. **Responsibilities**: To stay updated on changes in legislation and...
-
Regulatory Affairs Technician-solidos-top Pharma
hace 2 meses
Madrid, España NonStop Consulting A tiempo completoTengo una nueva vacante como Regulatory Affairs Technician (solidos) para una importante empresa farmaceutica, el puesto es indefinido y hay muy buen ambiente laboral, ademas ofrecen muchas oportunidades de promocion. La vacante es office based con un dia de teletrabajo a la semana. **Responsibilities**: To stay updated on changes in legislation and...