Current jobs related to Principal Scientist - Cork, Cork - Tn Ireland
-
Principal Environmental Scientist
4 days ago
Cork, Cork, Ireland Wellington Professional Recruitment Full timePrincipal Environmental Scientist / EIA ConsultantExcellent opportunity for a Senior Environmental Consultant to join our clients Environment team in Cork to work alongside engineers, environmental scientists, and other staff on a portfolio of infrastructure projects in Ireland, particularly in the water, energy and transport sectors, as well as on...
-
Cork, Cork, Ireland Life Science Recruitment Full timePrincipal Scientist Global Regulatory Affairs CMCPrincipal Scientist- Global Regulatory Affairs-CMCOur client, a global pharma company, is currently recruiting for a Principal Scientist- Global Regulatory Affairs-CMC for their Cork based manufacturing site.This is a permanent role with hybrid working.As Principal Scientist- Global Regulatory Affairs-CMC, you...
-
Cork, Cork, Ireland Atkinsréalis Full timeAbout the RoleThis is an exciting opportunity to join AtkinsRéalis's Environment team as a Principal Environment Scientist for Strategic Sustainability.The successful candidate will be responsible for managing large-scale environmental projects, including EIARs and non-statutory reports, while also motivating and mentoring junior team members. Strong...
-
Senior/Principal Water Quality Scientist
4 days ago
Cork, Cork, Ireland TN Ireland Full timeSocial network you want to login/join with:Senior/Principal Water Quality Scientist, CorkClient:Location: Cork, IrelandJob Category:OtherEU work permit required:YesJob Reference:4dd44ef7c4c4Job Views:4Posted:24.03.2025Expiry Date:08.05.2025Job Description:Job DescriptionAtkinsRéalis is one of the world's leading providers of environmental professional...
-
Principal Sustainability Expert
4 days ago
Cork, Cork, Ireland Wellington Professional Recruitment Full timePrincipal Sustainability ExpertWe are seeking a Principal Sustainability Expert to join our client's team in Cork. As a key member of the Environment team, you will work alongside engineers, environmental scientists, and other staff on a portfolio of infrastructure projects in Ireland, particularly in the water, energy, and transport sectors.This is an...
-
Principal Scientist
19 hours ago
Cork, Cork, Ireland Hobson Prior Full timeHobson Prior is seeking a Lead Scientist for Global Regulatory Affairs in Chemistry, Manufacturing and Controls.This role focuses on providing strategic and operational guidance for the development of Chemistry, Manufacturing and Controls processes.You will be involved in supporting worldwide clinical trials, market registration submissions, and...
-
Principal Scientist Technical Transfer
5 days ago
Cork, Cork, Ireland Life Science Recruitment Full timeJob DescriptionWe are seeking a skilled Senior Technical Scientist to join our team at Life Science Recruitment. This is an exciting opportunity for someone looking to advance their career in technical transfer and pharmaceutical manufacturing.
-
Cork, Cork, Ireland Wellington Professional Recruitment Full timeChartered Environmental Scientist ProfessionalWe are seeking a Chartered Environmental Scientist Professional to join our client's team in Cork. As a key member of the Environment team, you will work alongside engineers, environmental scientists, and other staff on a portfolio of infrastructure projects in Ireland, particularly in the water, energy, and...
-
Principal Scientist-Regulatory, GRA-CMC
3 weeks ago
Cork, Cork, Ireland Lilly Full timeWe're looking for people who are determined to make life better for people around the world. About Lilly At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to...
-
Principal Scientist
3 days ago
Cork, Cork, Ireland TTM Healthcare Full timeJob DetailsThis is a permanent full-time contract offering a competitive salary and benefits package. As a Senior Medical Scientist, you will have the opportunity to work with our team of experienced professionals, contributing to the delivery of high-quality patient care.Required Qualifications and ExperienceBe registered with CORU4 years experience in a...
-
Principal Environment Scientist
2 weeks ago
Cork, Cork, Ireland AtkinsRéalis Full timeAtkinsRéalis is one of the world's leading providers of engineering professional consulting and support services with offices across Ireland.We are seeking an ambitious Senior Environmental Consultant to join our Environment team to work alongside engineers, environmental scientists, and other staff on our portfolio of infrastructure projects in Ireland,...
-
CMC Pre-Approval Regulatory Scientist
2 weeks ago
Cork, Cork, Ireland Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Senior/Principal Hydromorphologist/Hydrologist
6 hours ago
Cork, Cork, Ireland TN Ireland Full timeSocial network you want to login/join with:Client:Location:Cork, IrelandJob Category:OtherEU work permit required:YesJob Reference:fbf43d9c4ecbJob Views:69Posted:21.01.2025Expiry Date:07.03.2025Job Description:Job DescriptionAtkinsRéalis is one of the world's leading providers of environmental professional consulting and support services with offices across...
-
Materials Scientist – Nanotechnology Development
17 hours ago
Cork, Cork, Ireland Tyndall National Institute Full timeJob DescriptionThe Tyndall National Institute is seeking a highly skilled researcher to join our team as a Research Fellow in Materials Science. The successful candidate will be responsible for designing and implementing a research program focused on the development of novel materials for semiconductor applications.The role involves working with the...
-
CMC Development Lead
1 day ago
Cork, Cork, Ireland HERO Recruitment Full timeKey Responsibilities:In this Principal Scientist - Global Regulatory Affairs - CMC role, you will:Support global clinical trial, market registration submissions, and post-approval submissions.Collaborate with cross-functional teams to drive CMC development and ensure timely delivery of regulatory submissions.Develop and maintain knowledge of regulatory...
-
Senior Environmental Consultant Lead
4 days ago
Cork, Cork, Ireland Wellington Professional Recruitment Full timeSenior Environmental Consultant LeadWellington Professional Recruitment is seeking a highly skilled Senior Environmental Consultant Lead to join our client's team in Cork. As a key member of the Environment team, you will work alongside engineers, environmental scientists, and other staff on a portfolio of infrastructure projects in Ireland.This is an...
-
Senior Research Chemist
1 day ago
Cork, Cork, Ireland Pepsico Deutschland Gmbh Full timeAbout the RoleWe are seeking a highly skilled Principal Scientist - Beverage Formulation to join our R&D team in PepsiCo Deutschland GmbH.The successful candidate will be responsible for formulating concepts, characterizing applications and modelling performance of powder and liquid-based consumer beverage products.Key ResponsibilitiesConcept formulation,...
-
Environmental Project Manager
4 days ago
Cork, Cork, Ireland Wellington Professional Recruitment Full timeEnvironmental Project ManagerWe are seeking an experienced Environmental Project Manager to join our client's team in Cork. As a key member of the Environment team, you will work alongside engineers, environmental scientists, and other staff on a portfolio of infrastructure projects in Ireland, particularly in the water, energy, and transport sectors.This is...
-
Principal Scientist Quality Auditor
4 weeks ago
Cork, Cork, Ireland Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Principal Scientist Quality Auditor
2 weeks ago
Cork, Cork, Ireland Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
Principal Scientist
2 weeks ago
Social network you want to login/join with:
Principal Scientist - CMC Pre-approval Regulatory, Cork City Client: Lilly
Location: Cork City, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: f55d426667da
Job Views: 81
Posted:
Expiry Date:
Job Description: We're looking for people who are determined to make life better for people around the world.
At Lilly, we serve an extraordinary purpose.
For more than 140 years, we have worked tirelessly to discover medicines that make life better.
These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world's greatest health challenges.
We give our best effort to our work, and we put people first.
We're looking for people who are determined to make life better for patients around the world.
Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidized canteen, onsite gym, travel subsidies and on-site parking.
Inhouse People Development services, Educational Assistance, and our 'Live Your BEST Life' wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
Eli Lilly Cork is committed to diversity, equity and inclusion (DEI).
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself
The CMC Pre-approval Principal Regulatory Scientist supports the various aspects of clinical trials and marketing authorization submission management processes.
The CMC Pre-approval Principal Scientist manages submission content for Drug Substance and Drug Product, and responses to questions.
The CMC Pre-approval Regulatory R3 Scientist in partnership with the GRA-CMC Regulatory Scientist provides tactical and operational direction to expedite CMC development of Lilly's portfolio and technical agenda by supporting clinical trial and market registration submissions.
These activities are accomplished with a strong working knowledge of global regulations, guidelines and regulatory precedence coupled with a strong technical knowledge of CMC development and manufacturing processes.
The CMC Pre-approval Regulatory R3 Scientist is responsible for networking with RDECMC Regulatory Associates to ensure proper communication and adherence to workflows to deliver on time submissions and responses to questions.
Primary Responsibilities: Plan and prepare submission content and responses to questions for clinical trials and marketing authorization applications.
Manage internal requirements and documentation within GRA and with internal Lilly partners (Development, TS/MS, Quality, etc).
Develop, plan and execute appropriate regulatory strategies and agreed-upon priorities through effective partnership with GRA-CMC Regulatory Scientists and other functional representatives, such as development, TS/MS, and quality.
Manage submission timelines with relevant teams (e.g., development, TS/MS, clinical teams), monitor approval status and communicate change status to interested personnel in a timely manner.
Partner with RDECMC Regulatory Associates to effectively support clinical trial and product submissions.
Lead, Influence, Partner: Create an environment within the Global Regulatory Area and across CMC teams that encourages open discussions on issues to achieve a robust outcome on project decisions.
Leverage internal forums to continue to develop and share regulatory expertise to meet critical clinical trial submissions/product registration timelines and electronic submission structure and content requirements.
Communicate effectively to guide and influence within work group/function regarding life-cycle management processes.
Demonstrate strong problem-solving skills and ability to address and effectively communicate regulatory issues across multiple functions and geographies.
Qualifications: Bachelor's degree in a science, engineering, or related field (Chemistry, Biology, Biochemistry, Pharmaceutics, Analytical Sciences or similar) with 6 – 8 years experience in CMC regulatory or drug substance or drug product development, commercialization, manufacturing or quality.
Or master's degree in regulatory affairs or in a science, engineering, or related field (Chemistry, Biology, Biochemistry, Pharmaceutics, Analytical Sciences or similar) with 3 – 5 years experience in drug substance or drug product development, commercialization, manufacturing or quality.
Less experience would be considered with a Pharm D or a PhD degree in a related field.
Other Information/Additional Preferences: Pharmaceutical industry experience in CMC technical drug development desirable.
Prior experience authoring CMC submission content is desirable.
Prior Regulatory CMC experience or equivalent combination of technical and regulatory guidance knowledge is desirable.
Demonstrated strong written, spoken and presentation communication skills.
Demonstrated negotiation and influence skills.
Demonstrated attention to detail and ability to prioritize effectively.
Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
#J-18808-Ljbffr
