Senior/manager, Regulatory Affairs
hace 7 meses
**Requisition Number**7883**
**Employment Type**:Regular**
**Who we are**
Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.
Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies
**Why Worldwide**
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us
**What you will do**
- Review study budgets and costing pertaining to contract negotiation, participate in business development activities, prepare regulatory sections of proposals and feasibility reports and attend bid defense meetings to meet business needs
- Coordinate & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions and ensure accurate compilation, management and tracking of submissions
- Provide expert regulatory advice and contribute to regulatory project work. Effectively communicate status of submissions with the Sponsor, Project Manager, CRAs, Medical & Scientific Affairs staff. Contribute towards the preparation of technical documentation such as IMPDs and IBs, review and make recommendations on all relevant documentation to ensure compliance with ICH GCP & country specific requirements
- Provide training, coaching and mentoring to junior members of staff, may be required to line manage junior members of staff
**What you will bring to the role**
- Clearly, proven leadership and organizational management skills are essential attributes
- Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills
- Excellent written and verbal communication skills to clearly and concisely present information
- Relationship-building competency combined with demonstrated comfort supporting Business Development at face-to-face meeting
- Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
- Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment
**Your experience**
- A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR
- Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) and eight years’ experience within clinical research (e.g. CRA, Reg Affairs.)
- Minimum 7 years within pharmaceutical/CRO industry, with demonstrated senior level regulatory or clinical start-up experience
- Proficient in cross-cultural communication and proficient in both spoken and written English
We love knowing that someone is going to have a better life because of the work we do.
-
Senior Regulatory Affairs Manager
hace 7 meses
Ourense provincia, España Worldwide Clinical Trials A tiempo completo**Requisition Number** **7297** **Employment Type***: **Regular** **Who we are** We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with...
-
Regulatory Affairs Officer, Spain
hace 2 semanas
Majadahonda, Madrid provincia, España Linical Europe A tiempo completoLinical Co., Ltd. (‘Linical’) is a premier global CRO headquartered in Osaka, Japan, listed in the prime segment of the Tokyo Stock exchange, and dedicated to serve its clients as a true partner in development. With approximately 900 employees Linical directly covers a total of more than 20 countries in Europe, North America and Asia-Pacific including...
-
Regulatory Affairs Trainee
hace 2 semanas
Mataró, Barcelona provincia, España HARTMANN A tiempo completoÚnase a nuestro equipo como **Regulatory Affairs Trainee** ESP-Mataró (Barcelona) Aprovecha la nueva oportunidad que te ofrece HARTMANN en el Área de Regulatory Affairs. **Responsabilidades** En relación con las comunicaciones de puesta en el mercado a la AEMPS por cada producto sanitario que ponemos en el mercado: - Reunir la documentación...
-
Regulatory Affairs Junior
hace 2 semanas
Salamanca provincia, España Page Personnel España A tiempo completoGestionar la preparación, presentación y mantenimiento de las autorizaciones de comercialización de los productos de la compañía. - Generar y recopilar toda la información interna y externa para la evaluación o mantenimiento de los dossiers. - Revisión y aprobación de etiquetado y materiales promocionales. - Seguimiento de los dossiers presentados a...
-
Regulatory Affairs Trainee
hace 2 meses
San Agustín de Guadalix, Madrid provincia, España BD A tiempo completo**Job Description Summary**: As Regulatory Affairs Trainee you will learn and develop from executing and supporting the activities of the Regulatory Affairs Operations team. The scope extends across BD business units and all EMEA countries. The activities are related with regulatory responsibilities to execute regulatory processes and provide support (with...
-
Regulatory Affairs Leader
hace 3 meses
Lliçà d'Amunt, Barcelona provincia, España Werfen A tiempo completo**Job Overview**: - Post Date - October 18, 2024 - Number - WEBOE-2024-000015 - Job Function - QA&RA - Location - Lliça d Amunt - Country - Spain **About the Position**: This position, Regulatory Affairs Leader, provides effective regulatory support for company’s manufactured products and customer’s products. Prepare and submit the documentation...
-
Energy Sourcing
hace 2 meses
Sant Joan Despí, Barcelona provincia, España Essity A tiempo completo**Energy Sourcing & Regulatory Affairs Manager - Spain** **About the Role** This position supports the strategy for Energy procurement in Spain by sourcing energy for high-consumption sites within the framework of the global energy risk policy. You will manage regulatory issues related to energy consumption in Spain, ensuring compliance and...
-
Regulatory Affairs Manager
hace 4 meses
Cornellà de Llobregat, Barcelona provincia, España Alcon A tiempo completoAt Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our...
-
Trainee Regulatory Affairs
hace 2 meses
Sant Cugat del Vallès, Barcelona provincia, España Grifols SA A tiempo completo¿Te gustaría unirte a un equipo internacional que trabaja para mejorar el futuro del sector de la salud? ¿Quieres contribuir a mejorar la vida de millones de personas? Grifols es una compañía global del sector de la salud que desde 1909 mejora la salud y el bienestar de las personas en todo el mundo. Somos líderes en medicamentos hemoderivados y...
-
Regulatory Affairs Associate Director
hace 3 meses
Palafolls, Barcelona provincia, España Sandoz A tiempo completoAs Regulatory Affairs Associate Director, you will lead associates within Regulatory API (RAPI), accountable for driving and delivering high quality documentation supporting successful submission, within agreed timelines and project planes. Including preparation of registration documentation and assessment of appropriateness of registration documentation for...
-
Fdf Regulatory Affairs Officer
hace 4 meses
08130 Santa Perpètua de Mogoda, Barcelona provincia, España GENUINE A tiempo completo**FDF REGULATORY AFFAIRS OFFICER** Nuestro cliente es una compañía farmacéutica española cuyo negocio está centrado en I+D, licencia, fabricación y suministro de productos farmacéuticos. Cuenta con un amplio conocimiento y experiência en ofrecer productos y soluciones de calidad en el ecosistema de la salud. Sus valores abanderan un alto compromiso...
-
Government Affairs Representative
hace 7 meses
Estrada, Pontevedra provincia, España TotalEnergies A tiempo completo**Pays** Mozambique **Lieu de travail** PEMBA-ESTRADA NACIONAL N106(MOZ) **Domaine** Communication, Gouvernance et Information **Lieu** Mozambique **Expérience** Minimum 6 ans - Appuyez sur les touches espace ou entrée pour alterner la visibilité de la section.- A minimum of bachelor and six years experience in public affairs, - Specific...
-
Associate Regulatory Director
hace 1 semana
Madrid provincia, España ADV Talent Partners A tiempo completo**About the Client** Our client is a R&D small pharma organization with a site in Amsterdam and with a specialty development pipeline focused on internal medicine, infectious diseases (antibiotics) and neurology. It is a small, friendly team with a stable working environment and the senior management are very inclusive. They are growing their portfolio and...
-
Clinical & Biocompatibility Expert. Regulatory
hace 2 semanas
Barcelona provincia, España Morgan Philips Executive Search A tiempo completoAs part of the Global Regulatory Affairs Team, we offer you an exciting and responsible task in a globally operating functional area. We enable our employees to get involved in interesting tasks in a modern working environment and to grow with them, as well as to develop professionally. If you are also enthusiastic about our meaningful product portfolio, we...
-
Medical Affairs Manager- Hematology
hace 4 meses
Sant Cugat del Vallès, Barcelona provincia, España Grifols SA A tiempo completoWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...
-
Resource Efficiency Manager
hace 7 meses
Ourense provincia, España DATA4 Group A tiempo completoABOUT THE ROLE The resource efficiency manager is a critical role at Data4 to ensure leading practices in terms of environmental impact and sustainability across all sites. To ensure future datacenters growth, it is critical to demonstrate excellent track record and very high engagement to reduce resource usage while keeping customer service quality. The...
-
Medical Affairs Dermatology Contractor
hace 2 semanas
Tres Cantos, Madrid provincia, España Incyte Corporation A tiempo completo**T**itle**:Medical Affairs Lead (contractor) Spain, IAI ( Inflammation and Immunology) **Department**:IAI** **Medical Affairs, Region Europe **Reports to**:IAI Medical Affairs lead Region Europe **Summary** This is the leadership position in IAI Medical Affairs in Spain, reporting to reporting to the IAI Medical Affairs lead Region Europe in a matrix...
-
Senior Project Manager Scrum Master
hace 7 meses
Ourense provincia, España Agile Content A tiempo completoWe are seeking a talented and experienced Senior Project Manager Scrum Master Location**: Anywhere in **Spain or Portugal. Enjoy working from home!** **Purpose of the role**: - As a Senior Project Manager, you will play a crucial role in ensuring the successful execution of projects from start to finish. From the moment a project enters the company until...
-
Vie - Junior Product Manager (Adhesives and
hace 7 meses
Berrioplano, Navarra provincia, España Saint Gobain A tiempo completo**Missions et responsabilités** Our Iberian team based in Pamplona is looking for a V.I.E to support the EMEA Product Manager for Adhesives and Sealants. A close relation with the **marketing** and **channel organizations** in Abrasives EMEA will be essential. - _**Main responsibilities**: - Support in creating safety data sheets, labels, and technical...
-
Senior Business Development Manager
hace 2 semanas
Ourense provincia, España Listgrove Ltd A tiempo completoCircular Economy, Sustainability, Polymers, Chemicals Based UK or Europe **Job ref**: **CST** **/** **57913** **The company**: Honeywell UOP is an innovator with advanced plastics recycling, long-term energy storage battery solutions and hydrogen technologies. They have an opportunity for a ** Senior Business Development Manager **to join their...