Global Regulatory CMC Project Lead
2 semanas atrás
We are seeking an experienced Regulatory CMC Manager to join our team in Portugal. As a key member of our global operations, you will play a pivotal role in overseeing and coordinating Regulatory CMC activities to support tech transfer projects.
Key Responsibilities:- Develop and Implement Global CMC Strategies: Design and execute comprehensive regulatory strategies to meet diverse global requirements across production sites.
- Manage Regulatory CMC Activities: Oversee the preparation, submission, and management of CMC documentation for regulatory filings.
- Coordinate Change Notifications: Manage change notifications to ensure timely and accurate regulatory updates across global markets.
- Stakeholder Collaboration: Build and maintain strong relationships with internal and external stakeholders, including regulatory agencies, supply chain teams, and manufacturing sites.
- Support Tech Transfers: Align Regulatory CMC activities with tech transfer processes, ensuring smooth transitions while maintaining compliance.
- Proven expertise in Regulatory CMC in a global environment, including regions such as Asia, LATAM, USA, and EU.
- Strong understanding of CMC regulatory requirements for pharmaceuticals, particularly solid dosage forms.
- Experience managing regulatory submissions and handling change control processes.
- Excellent communication and organizational skills to facilitate collaboration across cross-functional teams.
- Ability to manage complex projects and adapt plans to address unforeseen challenges.
- A competitive salary of €60,000 - €80,000 per year, depending on experience.
- An opportunity to lead high-impact global projects in a collaborative environment.
- Flexibility to work remotely, offering a healthy work-life balance.
- A chance to work with a global organization committed to innovation and patient-focused solutions.
-
Global Regulatory CMC Expert
4 semanas atrás
Lisboa, Lisboa, Portugal Buscojobs Portugal Tempo inteiroTFS HealthScience is a leading global Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. We provide full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions, helping bring life-saving treatments to patients worldwide.Sponsor: You will be...
-
Regulatory Affairs Chemistry Manufacturing Lead
2 semanas atrás
Lisboa, Lisboa, Portugal Biom?Rieux Bv Tempo inteiroBiomRieux Bv Job DescriptionOverview:We are seeking a highly skilled Associate Principal Scientist, Regulatory Affairs, Chemistry Manufacturing and Controls to join our team at BiomRieux Bv in Lisboa. This is an exciting opportunity for a talented professional to play a key role in facilitating and implementing Regulatory CMC strategies for assigned...
-
Regulatory Affairs Specialist
2 semanas atrás
Lisboa, Lisboa, Portugal Biom?Rieux Bv Tempo inteiroJob DescriptionWe are seeking an experienced Regulatory Affairs Specialist to join our team in a key role within our Regulatory Affairs department. The ideal candidate will have a strong background in Chemistry, Manufacturing and Controls (CMC) and experience in regulatory affairs.About the RoleThe successful candidate will be responsible for developing and...
-
Regulatory Chemistry Lead
1 semana atrás
Lisboa, Lisboa, Portugal Biom?Rieux Bv Tempo inteiroJob SummaryWe are seeking a highly skilled Regulatory Chemistry Lead to join our team at Organon. This is a critical role that requires expertise in regulatory chemistry, manufacturing, and controls (CMC) strategies.Key ResponsibilitiesGlobal Product Regulatory Strategies: Develop and implement global product regulatory strategies by performing assessments...
-
Lisboa, Lisboa, Portugal Biom?Rieux Bv Tempo inteiroJob OverviewWe are seeking a highly skilled Regulatory Affairs expert to join our team at Biom?Rieux Bv. As an Associate Principal Scientist, you will play a pivotal role in crafting global strategies for pharmaceutical success.About the RoleIn this key position, you will be responsible for facilitating and implementing regulatory CMC strategies for assigned...
-
Principal Regulatory Affairs Expert
3 semanas atrás
Lisboa, Lisboa, Portugal Organon Tempo inteiroJob OverviewThe Associate Principal Scientist, Regulatory Affairs, Chemistry Manufacturing and Controls position at Organon is a key role in facilitating and implementing global regulatory strategies for small molecule products. This expert will work closely with the CMC Product Lead to ensure the successful execution of project...
-
Senior Regulatory Affairs Specialist, CMC Strategy Expert
2 semanas atrás
Lisboa, Lisboa, Portugal Organón Tempo inteiroJob OverviewThe position of Associate Principal Scientist, Regulatory Affairs Chemistry Manufacturing at Organon is responsible for providing regulatory support for Organon Network Projects. This includes leading the preparation and submission of Chemistry, Manufacturing & Controls (CMC) dossiers for assigned projects.Main ResponsibilitiesManage processes...
-
Chemistry Manufacturing Lead for Regulatory Affairs
1 semana atrás
Lisboa, Lisboa, Portugal Organón Tempo inteiroJob Overview:Organon is a $6.5 billion global healthcare company focused on making a world of difference for women, their families, and the communities they care for.We are seeking an experienced Chemistry Manufacturing Lead to join our team in Regulatory Affairs. As a key member of our organization, you will be responsible for leading the preparation and...
-
Senior Regulatory Chemistry Expert
2 semanas atrás
Lisboa, Lisboa, Portugal Mygwork Tempo inteiroOrganon is a leading global healthcare company focused on delivering innovative health solutions for women and their families.About the RoleWe are seeking an experienced Senior Scientist to join our Regulatory Affairs team as a Senior Regulatory Chemistry Expert. This role will be responsible for implementing regulatory strategies for assigned products,...
-
Lisboa, Lisboa, Portugal Organón Tempo inteiro**Job Description:**The Associate Principal Scientist, Regulatory Affairs Chemistry Manufacturing position at Organon is responsible for providing regulatory CMC support for Network Projects. This role will lead the preparation and submission of CMC dossiers for assigned Network Projects.**Key Responsibilities:**Manage processes and connections between...
-
Lisboa, Lisboa, Portugal Organon Tempo inteiro**Job Summary:**We are seeking an experienced Regulatory Affairs Scientist to join our team at Organon. This role is responsible for facilitating and implementing regulatory CMC strategies for assigned small molecule products supporting site of source changes in accordance with global regulations and guidance.Key Responsibilities:Work closely with the CMC...
-
Regulatory Affairs Senior Specialist
2 semanas atrás
Lisboa, Lisboa, Portugal Biom?Rieux Bv Tempo inteiroAt Biom?Rieux Bv, we are seeking a highly skilled Regulatory Affairs Senior Specialist to join our team. This role is responsible for implementing regulatory strategies for assigned products in accordance with global regulations and guidelines. The ideal candidate will have a strong background in chemistry, manufacturing, and controls (CMC) and be proficient...
-
Senior Regulatory Affairs Lead for Chemistry and Manufacturing
4 semanas atrás
Lisboa, Lisboa, Portugal Organón Tempo inteiroAt Organon, we're committed to delivering ingenious health solutions that empower people to live their best lives. Our team is seeking a skilled Senior Regulatory Affairs Lead to oversee Chemistry and Manufacturing strategies across our Network Projects. This critical role will lead the preparation and submission of CMC dossiers, collaborating with...
-
Lisboa, Lisboa, Portugal Organon Tempo inteiroAbout the RoleThe Associate Principal Scientist, Regulatory Affairs, Chemistry Manufacturing and Controls is responsible for facilitating regulatory strategies for assigned products supporting Site of Source Changes in accordance with global regulations and Company procedures.This role will work closely with CMC Product Lead to ensure delivery of all...
-
Regulatory Affairs Chemistry Manufacturing Leader
4 semanas atrás
Lisboa, Lisboa, Portugal Organón Tempo inteiroJob OverviewThe Organon Manufacturing & Supply (OMS) is seeking a highly skilled Associate Director, Regulatory Affairs Chemistry Manufacturing to provide regulatory support for network projects. This role will lead the preparation and submission of CMC dossiers for assigned network projects.About the RoleThis position will oversee the preparation and...
-
Regulatory Affairs Chemistry Manufacturing Expert
2 semanas atrás
Lisboa, Lisboa, Portugal Organón Tempo inteiroOrganon is seeking an experienced Associate Principal Scientist to join our team in Regulatory Affairs Chemistry Manufacturing. This role will provide critical support for Organon's Network Projects, ensuring timely and high-quality submission of CMC dossiers. The ideal candidate will have a strong background in CMC strategy, project management, and...
-
Scientific Regulatory Affairs Expert
1 semana atrás
Lisboa, Lisboa, Portugal Biom?Rieux Bv Tempo inteiroJob OverviewBiom?Rieux Bv is seeking an experienced Scientific Regulatory Affairs Expert to join our team. In this role, you will be responsible for implementing regulatory strategies for assigned products in accordance with global regulations and guidance.Key ResponsibilitiesProvide input to global product and project regulatory strategies by performing...
-
Regulatory Affairs Expert for Women's Health Solutions
4 semanas atrás
Lisboa, Lisboa, Portugal Biom?Rieux Bv Tempo inteiroJob DescriptionSr. Scientist, Regulatory Affairs - Chemistry, Manufacturing & Controls (CMC)The Senior Scientist in this role will be responsible for implementing Regulatory Strategies for assigned products in accordance with global regulations and defined regulatory strategies.Key Responsibilities:Provide input to global product and project regulatory...
-
Regulatory Chemistry Expert
2 semanas atrás
Lisboa, Lisboa, Portugal Biom?Rieux Bv Tempo inteiroAbout UsAt Biom?Rieux Bv, we're dedicated to delivering ingenious health solutions that enable people to live their best lives. Our focus is on making a world of difference for women, their families, and the communities they care for.Career OpportunityWe are seeking an experienced Sr. Scientist, Regulatory Affairs to join our team as a Regulatory Chemistry...
-
Global Scientific Excellence Lead
Há 1 mês
Lisboa, Lisboa, Portugal Sgs Tempo inteiroJob OverviewThe Global Scientific Excellence Lead - Health Science is a critical role that oversees the laboratory service portfolio globally, ensuring that scientific and technical capabilities are adequate to support the business strategy. This position reports directly to the Health Science Management Team.About the RoleWe are seeking an experienced...