Regulatory Affairs Associate Director
hace 3 meses
.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 for active ingredients/intermediates.Your responsibilities will include:Lead, coach and mentor associates. Ensure sufficient training and development opportunities to maximize regulatory competence.Take responsibility for financial targets included but not limited cost center responsibility.Ensure and/or support timely and accurate reporting of regulatory activities.Perform and/or support analyzing group performance and making recommendations for improvement the team.Coordinate the preparation and execution of regulatory documents. Ensures regulatory CMC submissions are of high quality, consistent and complete, and comply with current global regulatory standards.Formulate, lead and drive global regulatory strategy with a focus on maximizing the business benefit balanced with regulatory compliance for drug substances.Generation, review and approval of internal regulatory guidance documents, protocols, reports within assigned projects.Establish and maintain sound working relationships with colleges, partners and customers. Provide regulatory guidance to cross-functional teams, and determine regulator impact for changes in chemistry, manufacturing, and control procedures. Support or/and lead global regulatory projects/initiatives.Keep knowledge up to date regarding regulatory guidelines and requirements in all global regions as well as for new technical trends. Responsibility for transfer of knowledge and experiences to the organization.Liaise under minor supervision with regulatory agencies and represent the company in regulatory meeting and discussions.Work according to internal and external guidance, SOPs and respective timelines.What you'll bring to the role:PhD (natural science: chemistry, pharmacy, biology or related substances) with at least 3 years work related post-doctoral / industrial experience or Master/BSc (natural science: chemistry, pharmacy, biology or related substances) with at least 3 years of work related experience including people management experience.Leadership experience within regulatory affairs function.Broad knowledge on Module 3.Broad knowledge of regulatory guidelines.Good knowledge of relevant software tools.Good skills in presentation and scientific/technical writing.Good documentation skills and able to understand and exactly follow written procedures.Fluent oral and written English. Fluent Spanish.Why Sandoz? Generic and Biosimilar medicines are the backbone of the global medicines industry
-
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...
-
Regulatory Affairs Associate
hace 4 semanas
Barcelona, España buscojobs España A tiempo completoRegulatory Affairs AssociateBarcelona, CataloniaGalderma - 28.11.2024With 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 approach to dermatological care.Regulatory Affairs AssociateBarcelona, CataloniaGlobal...
-
Regulatory Affairs Associate
hace 4 semanas
Barcelona, España buscojobs España A tiempo completoRegulatory Affairs AssociateBarcelona, CataloniaGalderma - 28.11.2024With 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 approach to dermatological care.Regulatory Affairs AssociateBarcelona, CataloniaGlobal...
-
Associate Director, Regulatory Affairs
hace 2 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...
-
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...
-
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 4 semanas
Barcelona, España buscojobs España 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 plans. This includes preparation of registration documentation and assessment of appropriateness of registration documentation...
-
Regulatory Affairs Associate Director
hace 4 semanas
Barcelona, España buscojobs España 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 plans. This includes preparation of registration documentation and assessment of appropriateness of registration documentation...
-
Regulatory Affairs Associate Director
hace 4 semanas
Barcelona, España buscojobs España 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 plans. This includes preparation of registration documentation and assessment of appropriateness of registration documentation...
-
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...
-
Associate Director, Regulatory Affairs
hace 2 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 2 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 2 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....
-
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...
-
? (Aplica Ya) Associate Director, Regulatory Affairs - Cmc
hace 2 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...
-
Regulatory Affairs Associate
hace 3 semanas
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 Associate |
hace 1 semana
Barcelona, España Reckitt A tiempo completo.We're a growing community of 43,000+ diverse, talented entrepreneurs - united in the relentless pursuit of a cleaner, healthier world.Drawing on each other's skills and working together, we put people at the heart of our business.Through research and development, science, and partnership, we make products that people have loved and trusted for...
-
Regulatory Affairs Associate |
hace 1 semana
Barcelona, España Reckitt A tiempo completo.We're a growing community of 43,000+ diverse, talented entrepreneurs - united in the relentless pursuit of a cleaner, healthier world.Drawing on each other's skills and working together, we put people at the heart of our business.Through research and development, science, and partnership, we make products that people have loved and trusted for...
-
Regulatory Affairs Senior Director
hace 2 semanas
Barcelona, Barcelona, España Sandoz A tiempo completoSandoz, a leading global pharmaceutical company, offers an exciting opportunity for a Regulatory Affairs Senior Director to join our team. This role is responsible for leading regulatory strategies and ensuring compliance with global regulations in the development and commercialization of generic and biosimilar medicines.Job OverviewThe Regulatory Affairs...
