Executive Regulatory Science
hace 2 semanas
Within Oncology Regulatory Affairs, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to those who need it - working across our pipeline and the business to get medicines to patients as efficiently and optimally as possible. As an industry leading Oncology Regulatory function, we’re growing fast, and we’re as passionate about and committed to the development of our people as we are our business - providing an open and encouraging space to explore, learn, grow and develop across all roles and levels.
At AstraZeneca, we share and are motivated by the same purpose: pushing the boundaries of science in order to deliver life-changing medicines to patients around the world. Everything we do is underpinned by our dedication to being a phenomenal Place to Work. We recognize that our people are our greatest asset and know what’s possible with an accomplished and diverse team that believes in what science can do.
We are more than 65,000 people in over 100 countries. Our aim is simple: to positively impact lives, together. Using the power of science and innovation, our people improve the impact medicine has on patients. Together, we explore the limitless world of science through our remarkable product pipeline, and we take our understanding of many therapeutic areas to a whole new level by seeking new treatments.
**How you will make a difference**:
- Coach and mentor regional (US and EU regulatory leads) and global regulatory leads, including identification of skill development opportunities regulatory professionals with different levels of experience.
- Partner with Regulatory Affairs Directors aligning on global innovative regulatory strategies for products.
- Lead resource planning and recruitment of staff.
- Provide critical review and input on disease area and portfolio regulatory strategies, risk planning and mitigations.
- Effectively represent the Global Regulatory Affairs function in senior level interactions at internally governance technical review committees, key global health authority meetings and external partners.
- Collaborate with regional policy and intelligence groups to critically analyze the assessment of emerging science, data and changes in the regulatory environment and advise senior management on project risks/mitigation activities accordingly.
- Define and drive disease area global regulatory policies and priorities.
- Review and approve high-level documents for global regulatory submissions as well as core prescribing information.
- Ensure submission excellence framework is timely and consistently applied across projects including sharing the best submission practices and knowledge and using existing tools.
**What You'll Need**:
- Bachelor’s degree in life sciences and/or science related field and/or other appropriate knowledge/experience.
- More than 10 years drug development experience.
- Oncology therapy area knowledge/experience.
- Significant experience in leading major health Authority interactions
- Proven experience of growing high performance teams, attracting top talent, and developing capabilities of regional and global regulatory leads. Experience in leading people in a matrixed interpersonal structure
- Ability to think strategically and critically to evaluate risks to regulatory product development and approval, market entry and license maintenance activities.
- Ability to travel domestically and internationally.
**Preferred**:
This role can be located at our following sites: Gaithersburg, Waltham, Mississauga, or Barcelona
**Why AstraZeneca?**
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey.
**So, what’s next**
- Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
**Where can I find out more?
-
Regulatory Affairs Manager
hace 2 días
Barcelona, España AstraZeneca A tiempo completoAt AstraZeneca, we're not just about treating diseases - we're about defeating them. We're on a mission to turn innovative science into life-changing medicines, and we need your help. As a Reg Affairs Manager in our Oncology R&D department, you'll play a crucial role in gaining approval for our novel work on unmet medical needs. If you're ready to make a...
-
Regulatory Affairs Associate Director
hace 2 días
Barcelona, España AstraZeneca A tiempo completoWelcome to AstraZeneca, where we prioritize patients and strive to meet their needs globally. We are a team of entrepreneurial thinkers, big dreamers, and collaborators who work together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of...
-
Consultor Selección
hace 7 días
Barcelona, España Lambda Executive A tiempo completoDesde Lambda Executive,firma de headhunting especializada en nichos tecnológicos, técnicos y científicos de mandos intermedios y directivos, y como parte del crecimiento que estamos experimentando gracias a nuestros servicios de alto valor en consultoría de selección, estamos buscando un Manager para liderar el equipo de Life Science.Tus principales...
-
Regulatory Affairs Director
hace 2 días
Barcelona, España AstraZeneca A tiempo completoAt AstraZeneca, we do this with the upmost integrity even in the most sophisticated situations because we are committed to doing the right thing! We continuously forge partnerships that help bring world-class treatments to patients in new ways, combining our people’s outstanding skills with those of people from all over the globe. Within Oncology...
-
International Cmc Regulatory Affairs Director
hace 2 días
Barcelona, España AstraZeneca A tiempo completoWelcome to AstraZeneca, where we prioritize patients and strive to meet their needs globally. We are a team of entrepreneurial thinkers, working together to turn the impossible into reality. If you are action-oriented, confident in leadership, collaborative, and curious about the potential of science, then you are the perfect fit for us. Join our Chemistry,...
-
Quality Assurance
hace 4 días
Barcelona, España Winid A tiempo completoQuality Assurance & Regulatory Affairs Manager Winid is a talent acquisition consultancy that offers Executive Search, RPO and Talent Solutions. Our purpose is to drive the growth and fulfillment of individuals and organizations. We facilitate individuals in finding inspiring opportunities and help organizations discover professionals who will take them to...
-
Associate Manager, Clinical Trials Regulatory Management
hace 2 semanas
Barcelona, España IQVIA A tiempo completoPrepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for more complex projects. RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on global projects which may be complex Ability to administratively and technically/scientifically review core scientific...
-
Statistical Science Associate Director
hace 4 semanas
Barcelona, España AstraZeneca A tiempo completo**Short role description** The Statistical Science Associate Director has sufficient experience working as a statistician in the pharmaceutical industry to independently perform and lead statistical work within a project, an indication within a more complex project or be recognised as a methodology expert. This individual is able to lead and direct...
-
Senior Statistical
hace 4 semanas
Barcelona, España AstraZeneca A tiempo completo**Primary location: Barcelona, Spain (On-site)** **Competitive salary and benefits** Statistical Science Associate Director - Early BioPharmaceuticals **Competitive salary and benefits** We are currently recruiting for **Statisticians **at **Associate Director **or **Senior **level** depending on your previous experience to join our growing team...
-
Regulatory Affairs Specialist
hace 1 mes
Barcelona, España PUIG, S.L. A tiempo completoThe Opportunity Responsible for assessing and ensuring regulatory compliance of cosmetic raw materials and home care products towards chemical and cosmetic regulations and warranting conformity with internal policy. What you'll get to do Home Care Products: Carrying out hazard calculation in accordance with the classification criteria for dangerous...
-
Regulatory Affairs Specialist
hace 4 semanas
Barcelona, Barcelona, España PUIG, S.L. A tiempo completoThe OpportunityResponsible for assessing and ensuring regulatory compliance of cosmetic raw materials and home care products towards chemical and cosmetic regulations and warranting conformity with internal policy. What you'll get to doHome Care Products:Carrying out hazard calculation in accordance with the classification criteria for dangerous mixture...
-
Statistical Science Associate Director
hace 4 días
Barcelona, España AstraZeneca A tiempo completo**Primary location: Barcelona, Spain (On-site)** **+ Poland, Warsaw** **Competitive salary and benefits** **Statistical Science Associate Director (Principal level) / Senior Statistician **- Early BioPharmaceuticals** **Competitive salary and benefits** We are currently recruiting for **Statisticians **at **Associate Director **or **Senior **level**...
-
Regulatory and Start Up Specialist 1
hace 6 días
Barcelona, España IQVIA A tiempo completoob 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. At least 1 years' experience with submissions and...
-
Eda Data Science Senior Manager
hace 4 semanas
Barcelona, España Autodesk A tiempo completoJob Requisition ID # - 23WD73736 Position Overview The Enterprise Data and Analytics (EDA) organization is on a mission to empower accurate decisions using certified customer data and insights product across all Autodesk customer-facing teams. The data science team is at the heart of developing and delivering Decision Intelligence solutions for both...
-
Senior Statistician/ Statistical Science Associate
hace 4 semanas
Barcelona, España AstraZeneca A tiempo completo**Primary location: Barcelona, Spain (On-site)** **Secondary locations: Macclesfield, UK; Gothenburg, Sweden; Warsaw, Poland** **Competitive salary and benefits** We are currently recruiting** a Statistician **at **Senior level** or **Associate Director **depending on your previous experience to join our growing team supporting the Early Respiratory &...
-
Statistical Programming Associate Director
hace 6 días
Barcelona, España Morgan Philips Executive Search A tiempo completoWe are recruiting Statistical Programmer to support our growing Early stage Cardiovascular, Renal & Metabolism portfolio at a Statistical Programming Associate Director level. **What you’ll do**: The Statistical Programming Associate Director provide Statistical Programming support and/or lead all programming related activities of the analysis and...
-
Senior Director Measurement Science
hace 4 semanas
Barcelona, España AstraZeneca A tiempo completoWe’re building out a best in class Measurement Science team to support the R&D portfolio as well as digital therapeutics, which will be part of the future of measurement science and analytics to support novel endpoints/interventions. **What you’ll do**: As the Senior Director Manager, you will play a pivotal role in leading our scientific capabilities...
-
Senior Director Measurement Science
hace 4 semanas
Barcelona, España AstraZeneca A tiempo completo**Evinova** We’re building out a best in class Measurement Science team to support the R&D portfolio as well as digital therapeutics, which will be part of the future of measurement science and analytics to support novel endpoints/interventions. **What you’ll do**: As the Senior Director Manager, you will play a pivotal role in leading our scientific...
-
Swedish Speaking Partner Sales Development Executive
hace 4 semanas
Barcelona, España IT Jobs Worldwide A tiempo completoSwedish speaking Partner Sales Development Executive **Job details**: **Location** Barcelona **Discipline** - IT**Reference** 35331 **Contact Name** Helene Bellos **Job description**: SAP Barcelona Our client's company culture is focused on helping their employees enable innovation by building breakthroughs together. How? They focus every day on...
-
Senior Account Executive
hace 6 días
Barcelona, España Omnicom Health Group A tiempo completoOverview: **Account Executive** LOCATION: Viriat 47, Floor 12 & 13, Numancia Building 1, Barcelona **About CDM Barcelona**: As part of one of the world’s most admired healthcare advertising agencies, CDM Barcelona brings people, brands, ideas and innovation together to change real lives in extraordinary ways. Our core values allow us to work with...