Associate Regulatory Affairs Specialist

**Job Description**: The Regulatory Affairs Senior Associate will perform regulatory related activities in the Portuguese Affiliate, with accountability to the Quality & Governance Manager who has the area oversight. The Regulatory Affairs Senior Associate acts as backup of the Qualified Person, according to the local regulations and as backup contact for...

Job Description : As a Regulatory Affairs officer, your responsibilities will include:Update and maintain technical documentation for medicinal products in accordance with applicable regulatory requirements, including but not limited to the EU guidelines, and other global regulatory frameworks.Collaborate with cross-functional teams, including R&D, Quality...

REGULATORY AFFAIRS MANAGER PERFIL DA **Função**: - Preparação e submissão de pedidos de AIM de medicamentos (procedimento nacional, MRP, DCP); - Preparação e submissão de alterações aos termos de AIM de medicamentos (procedimento nacional, MRP, DCP); - Atualização de bases de dados; - Atualização de informação do medicamento: RCM, FI e...

Your new company Multinational company in health area.  Your new position Pharmacovigilance: - Post-marketing safety case handling; - Literature review (of the results sent by the external vendor); - Monitoring of regulatory submissions PV related; - Submission of PV clinical documentation to CA (SUSAR reports and DSURs); - Elaboration of SUSAR line...

This role requires a versatile and flexible person, able to assume responsibilities and tasks horizontally and vertically, as well as to fill the gap between the work done by consultants and the manager. The main mission will be to work with and support the rest of the team in the design and implementation of consulting work for companies that need strategic...

EDP is a global energy company, which leads based on the values of Innovation, Sustainability, and Humanization. Using the technology of the future, we create solutions that are highly focused on the needs of our people and our customers, never neglecting our role and contribution to society. **Workplace**:Portugal or Spain Under the guidance of H2BU's...

**Publicado** - 17-Apr-2024**Salário** **Localização** - Lisboa**Categoria** - Prestador de Serviços**Sector** - Ciência**Referência** - BBBH670022**Descrição** Kelly Science and Clinical is currently recruiting a QA / RA Associate, to work in the Lisbon area, with a Pharmaceutical and Medical Devices Consultancy company. Responsibilities as a QA...

Clinical Research Associate **Category**:Clinical Development**Location**:Lisbon, Lisbon, PT- Are you an experienced Clinical Research Associate (CRA) looking for a new opportunity? Are you looking to advance your career in a dynamic and supportive environment? We have an exciting opportunity for you to join our team, based in either Lisbon or Porto!- **The...

Senior Public Affairs Consultant – LisbonWhat profile are we looking for?This role requires a versatile and flexible person, able to assume responsibilities and tasks horizontally and vertically, as well as to fill the gap between the work done by consultants and the manager. The main mission will be to work with and support the rest of the team in the...

A reportar ao Manager da área, terá como missão contribuir para o desenvolvimento e implementação das atividades de Public Affairs, contribuindo para o reforço da marca e comunicação corporativa e atuando junto aos principais stakeholders, de forma a garantir a presença da organização e suas iniciativas nos meios de comunicação e em entidades...

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 - Small Molecule at Mantell Associates Mantell Associates is partnered with an innovative Pharmaceutical organisation in their search for a Commercial Director. Commercial Director - Responsibilities: Define and develop the strategy to consolidate and scale up OTC business in Europe Work with country General Managers, Commercial Directors, Sales...

Junior Clinical Research Associate **Category**:Clinical Development**Location**:Lisbon, Lisbon, PT- Are you passionate about clinical research? Do you already have some experience as a Clinical Research Associate, Study Coordinator or CTA? Do you want to build your career in one of the most leading companies in the worldwide pharmaceutical industry and...

**About Medtronic** Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to...

I am actively seeking an experienced RA professional with excellent communication skills and a business mind-set who will provided value-added input to internal stakeholders and clients for a medium-sized pharmaceutical company located in Basel that is growing rapidly. In this exciting and challenging position you will take full responsibility for your...

At Galp, we believe that together we can make a difference in society by contributing to a more sustainable energy future. Changes starts with our people, where agility, continuous improvement, internal alignment and external focus are the values that define our organization where everyone, without exception, can reach their ultimate potential. We're...

At Galp, we believe that together we can make a difference in society by contributing to a more sustainable energy future. Changes starts with our people, where agility, continuous improvement, internal alignment and external focus are the values that define our organization where everyone, without exception, can reach their ultimate potential. We're...

Senior Clinical Research Associate IQVIA is the Human Data Science Company oriented to drive human health outcomes forward. When you join IQVIA Portugal as a sponsor-dedicated CRA, you'll enjoy the stability and resources of a leading, global contract research organization while gaining direct experience with one of our customers. With access to...

Essential Functions - Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project...

**Company Description** We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs...