International Cmc Regulatory Affairs Director
hace 9 meses
**About AstraZeneca**
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working 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 person.
**Chemistry, Manufacturing, and Controls (CMC)**
Our Chemistry, Manufacturing, and Controls (CMC) Regulatory function spans across the product lifecycle and are responsible for the regulatory strategy relating to the development, manufacture and testing of all of our medicines.
With our expertise we interpret, anticipate and shape global Health Authority expectations to build insightful CMC and Device Regulatory Strategies.
**What you will do**
- Provide International CMC RA expertise across the business functions. May lead key business improvement initiatives. May sit on external industry groups.
- Provide operational, tactical, and strategic International CMC RA expertise and direction for CMC submissions across the lifecycle of a product.
- Where necessary lead CMC related interactions with Health Authoritiesfor the international markets.
- Accountable for the provision of expert regulatory strategic guidance and delivering the CMC Regulatory Submissions in support of in support new products and lifecycle management Ensure project activities managed are delivered for assigned projects to a high standard, agreed time scales and meet the AZ business requirements, compliance requirements and regulatory authority expectations worldwide.
- Contribute to policy setting and strategy development in the International CMC RA environment within or external to AstraZeneca.
- Lead knowledge sharing and provide coaching both within CMC RA and wider business functions. Lead/contribute to Community of Practises across the groups or within a business unit.
- Accountable for managing high level risk by making complex judgments, developing innovative solutions including proactive risk management and mitigation.
- Provide AZ technical functions clear, concise guidance on current International CMC regulatory requirements to support business tactical strategic planning. Provide expert recommendation and decisions on regulatory issues relating to International CMC.
- Support the implementation of agile and novel approaches in CMC Dossier Management that drive new ways of thinking to enhance flexibility efficiency and flexibility.
- Participate and /or lead due diligence teams as necessary.
- Contribute to cross SET non-drug projects and act as business owner for business processes to ensure accelerated submissions, support launch activities / management of regulatory information and ensure regulatory compliance on behalf of AZ.
- Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
**Essential Requirements**
- Degree /PhD or equivalent professional qualification in a science or technical field such as pharmacy, biology, chemistry or biological science.
- Breadth of knowledge of manufacturing, project, technical and regulatory project management.
- Strong understanding of regulatory affairs globally
- Direct Regulatory Affairs CMC experience with submissions for Synthetics and/or biologic and biotechnology derived products
- Stakeholder & Project management
- Professional capabilities: Regulatory knowledge
**Why AstraZeneca?**
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
-
Cmc Regulatory Affairs Associate Director
hace 3 meses
Barcelona, España AstraZeneca A tiempo completo**Location: Barcelona, Spain (we requiere 3 days working from the office and 2 days working from home** Our **Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs** function delivers expert CMC regulatory input for projects spanning across the product lifecycle and leads the regulatory strategy for the development, manufacturing and testing of...
-
International Cmc Regulatory Affairs Director
hace 8 meses
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,...
-
Regulatory Affairs Cmc Specialist
hace 3 meses
Barcelona, España Mcr International A tiempo completoMFC-2409-303 REGULATORY AFFAIRS CMC SPECIALIST BARCELONA Desde MCR International , nos encontramos colaborando con una importante compañía farmacéutica en la búsqueda de un Técnico de Regulatory Affairs CMC .Funciones: Dar soporte regulatorio en los desarrollos de medicamentos de la compañía.Preparar la documentación necesaria.Gestionar la...
-
Regulatory Affairs Cmc Specialist
hace 3 meses
Barcelona, España Mcr International A tiempo completoMFC-2409-303REGULATORY AFFAIRS CMC SPECIALISTBARCELONADesde MCR International , nos encontramos colaborando con una importante compañía farmacéutica en la búsqueda de un Técnico de Regulatory Affairs CMC .Funciones:Dar soporte regulatorio en los desarrollos de medicamentos de la compañía.Preparar la documentación necesaria.Gestionar la interlocución...
-
Cmc Regulatory Affairs Director
hace 2 semanas
Barcelona, España AstraZeneca A tiempo completoAre you a strategically focussed Regulatory CMC professional and would like to play an integral part in bringing life changing medicines to patients? If you are please read on! **About AstraZeneca** At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working...
-
Associate Director, Regulatory Affairs
hace 3 semanas
Barcelona, España Astrazeneca Gmbh A tiempo completoPosition Summary The Associate Director, CMC Regulatory Affairs supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early-stage T cell therapies. This position is hybrid, and may be based in Santa Monica, CA or Gaithersburg, MD and reports to the Executive Director, CMC Regulatory Affairs....
-
Associate Director, Regulatory Affairs
hace 3 semanas
Barcelona, España Astrazeneca Gmbh A tiempo completoPosition Summary The Associate Director, CMC Regulatory Affairs supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early-stage T cell therapies. This position is hybrid, and may be based in Santa Monica, CA or Gaithersburg, MD and reports to the Executive Director, CMC Regulatory...
-
Associate Director, Regulatory Affairs
hace 3 semanas
Barcelona, España Astrazeneca Gmbh A tiempo completoPosition SummaryThe Associate Director, CMC Regulatory Affairs supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early-stage T cell therapies. This position is hybrid, and may be based in Santa Monica, CA or Gaithersburg, MD and reports to the Executive Director, CMC Regulatory...
-
Associate Director, Regulatory Affairs
hace 3 semanas
Barcelona, España Astrazeneca Gmbh A tiempo completoPosition SummaryThe Associate Director, CMC Regulatory Affairs supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early-stage T cell therapies. This position is hybrid, and may be based in Santa Monica, CA or Gaithersburg, MD and reports to the Executive Director, CMC Regulatory...
-
Associate Director, Regulatory Affairs
hace 3 semanas
Barcelona, España AstraZeneca GmbH A tiempo completoPosition Summary The Associate Director, CMC Regulatory Affairs supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early-stage T cell therapies. This position is hybrid, and may be based in Santa Monica, CA or Gaithersburg, MD and reports to the Executive Director, CMC Regulatory Affairs....
-
? (Aplica Ya) Associate Director, Regulatory Affairs - Cmc
hace 3 semanas
Barcelona, España Astrazeneca Gmbh A tiempo completoPosition SummaryThe Associate Director, CMC Regulatory Affairs supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early-stage T cell therapies. This position is hybrid, and may be based in Santa Monica, CA or Gaithersburg, MD and reports to the Executive Director, CMC Regulatory...
-
Cmc Regulatory Affairs Associate Director Biologics
hace 3 meses
Barcelona, España AstraZeneca A tiempo completo**CMC Regulatory Affairs Associate Director Biologics** **Location - Barcelona** **Competitive salary and benefits package** **Introduction to role** Join our dynamic team at AstraZeneca as a CMC Regulatory Affairs Associate Director. Based in our Barcelona, Spain hub, you will be a core member of our cross-functional Regulatory Strategy,...
-
Regulatory Affairs Associate Director
hace 8 meses
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...
-
International Cmc Regulatory Affairs Manager
hace 8 meses
Barcelona, España AstraZeneca A tiempo completo**Job Description**: **About AstraZeneca** At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working 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...
-
Regulatory Affairs
hace 4 días
Barcelona, España MCR International A tiempo completo**REB-2211-83** **REGULATORY AFFAIRS** **BARCELONA** Desde **Solo Talento, División de MCR International** estamos buscando **Regulatory Affairs** para nuestro cliente. **Funciones**: - Preparación de toda la documentación necesaria para realizar variaciones de dossier de registro de medicamentos (módulo 3 - CMC). Importante persona que prepare de...
-
International Cmc Regulatory Affairs Associate
hace 8 meses
Barcelona, España AstraZeneca A tiempo completo**About AstraZeneca** At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working 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...
-
Cmc Regulatory Affairs Manager
hace 1 mes
Barcelona, España AstraZeneca A tiempo completoAt AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big, and working 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 person. Our Chemistry,...
-
Regulatory Affairs
hace 2 días
Barcelona, España Mcr International A tiempo completo**REB-2211-83****REGULATORY AFFAIRS****BARCELONA**Desde **Solo Talento, División de MCR International** estamos buscando **Regulatory Affairs** para nuestro cliente.**Funciones**:- Preparación de toda la documentación necesaria para realizar variaciones de dossier de registro de medicamentos (módulo 3 - CMC).Importante persona que prepare de 0 la...
-
Senior Regulatory Affairs Director
hace 1 mes
Barcelona, España Astrazeneca Gmbh A tiempo completo.At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional...
-
Regulatory Affairs Manager
hace 8 meses
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...
