Cmc Regulatory Affairs Associate Director Biologics
hace 3 meses
**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, Biopharmaceutical and Global Supply Teams. This role is an opportunity to support the biologics technical area, encompassing both traditional and novel molecules. We pride ourselves on our encouraging culture and cross-project knowledge sharing. Are you ready to unlock knowledge and learning opportunities with us?
**Accountabilities**
As a CMC Regulatory Affairs Associate Director, your responsibilities will include devising creative strategies to support a range of new biologics and novel products, from development to post approval lifecycle management. You will provide strategic, tactical and operational expertise and direction to AstraZeneca project teams, handle high level risk, support project driven regulatory interactions with health authorities, lead and/or deliver CMC Regulatory components of business process improvement projects, and share your knowledge actively within CMC RA and the wider business.
**Essential Skills/Experience**:
- Bachelor’s degree or equivalent experience in a science or technical field such as pharmacy, biology, chemistry or biological science
- Significant experience of working in one or more areas in regulatory affairs in the biopharmaceutical industry, or in regulatory drug development, product approval/launch, line extension and license maintenance, or experience at a health authority
- Project and process management skills
**Desirable Skills/Experience**
- Advanced degree or equivalent experience in a science or technical field such as pharmacy, biology, chemistry or biological science
- Regulatory experience across global projects and several regions for antibody drug conjugates, radioconjugates or bispecifics
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca, we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We are all compassionate team players and driven achievers, always ready to step up. We're motivated by science, success and achieving our goals in a way that's novel and thoughtful. We see change as an opportunity, embracing the possibility to learn, grow and evolve.
Are you ready to be trusted and empowered to be the best you can be? Here we thrive in our inclusive, diverse and bold environment. We draw on our diverse knowledge to take smart risks and uncover new and creative ways to deliver better for our patients and our business.
Join us today Be part of a team that is striving for technology adoption and automation to drive efficiencies and new innovations. Be an integral part of bringing life-changing medicines to people.
-
Cmc Regulatory Affairs Associate Director
hace 4 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...
-
Associate Director, Regulatory Affairs
hace 1 mes
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 1 mes
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 1 mes
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 1 mes
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 1 mes
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....
-
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...
-
Biopharma Cmc Regulatory Affairs Consultant
hace 2 días
Barcelona, España G&L Scientific Inc. A tiempo completoG&L Scientific is the world’s fastest-growing independent scientific consultancy providing Pharmaceutical and Biotechnology clients throughout the world with expert Regulatory Affairs consultancy and Quality Assurance solutions. As demand for our services and solutions continues to increase, we have multiple openings in our global team for Regulatory...
-
Cmc Regulatory Affairs Director
hace 4 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...
-
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 Director
hace 9 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...
-
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 Associate Director
hace 3 meses
Barcelona, España Sandoz A tiempo completo.As 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...
-
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...
-
Regulatory Affairs Associate Director
hace 3 meses
Barcelona, 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...
-
Cmc Expert
hace 7 meses
Barcelona, España Asphalion A tiempo completo**Main responsibilities**: - CMC project lead/responsible person, reporting to CMC Director. - Overall CMC writing/management of product-specific dossiers (Mod. 2/Mod. 3), including, but not limited to, new registration packages, variation packages and renewal packages in the EU, US and RoW markets. - High-quality strategic support to CMC roadmaps, dossier...
-
Cmc Regulatory Affaris
hace 5 horas
Barcelona, España Oxford Global Resources A tiempo completoJob Title: Sr. Regulatory Affairs CMCLocation: Barcelona (50% home-based)Division: Life SciencesIntroduction to Oxford Global Resources:Oxford Global Resources is a trusted partner for providing specialized staffing and consulting solutions worldwide.With a focus on delivering quality, we connect highly skilled professionals to critical roles in the life...
-
Senior Regulatory Affairs Director
hace 2 meses
Barcelona, España Astrazeneca Gmbh A tiempo completoAt 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 Associate
hace 1 mes
Barcelona, España Galderma Pharma S.A A tiempo completo.Regulatory Affairs Associate With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology...
-
Regulatory Affairs Director
hace 7 meses
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...
