Regulatory Intelligence Specialist Position
hace 2 semanas
When our values align, there's no limit to what we can achieve.
We are seeking a highly motivated and detail-oriented Regulatory Intelligence Specialist to play a crucial role in maintaining our compliance standards. The successful candidate will be responsible for Regulatory Intelligence activities, ensuring that Parexel stays up to date with regulatory updates and implements relevant requirements.
Key Responsibilities:
- Lead and coordinate all Regulatory Intelligence activities, including research on regulatory updates, communication to stakeholders, and tracking the impact and implementation actions.
- Act as the point person for regulatory intelligence related consultancy.
- Assist the Parexel Quality group in the preparation for and follow-up of internal/external audits and inspections, as needed and relevant to Regulatory Intelligence Activities.
- Maintain the Regulatory Intelligence SharePoint and filing areas.
- Provide technical knowledge where appropriate.
- Collaborate with Parexel Quality to develop and update quality/process documents, tools, and templates in line with regulatory intelligence activities.
- Generate metrics on Regulatory Intelligence Activities.
- Contribute to the metrics provided to Senior Management.
- Complete assigned goals for key QMS elements, with a special focus on Knowledge Management/Regulatory intelligence activities and oversight.
- Undertake other duties as assigned.
Skills and Experience required for the role:
- Educated to degree level (technology, biological science, pharmacy, or other health-related discipline preferred) or equivalent qualification or clinical research experience.
- Experience in Quality Assurance, Quality Management, Regulatory Affairs, Clinical Research, Monitoring, Data Management, Pharmacy, Laboratory, or other relevant areas.
- Good understanding of regulatory affairs landscape.
- Experience working with clinical trials.
- Project management capabilities applicable to Regulatory Intelligence activities and oversight.
- Excellent interpersonal, verbal, and written communication skills, including the ability to present at meetings and training sessions.
- Ability to rapidly learn, understand, and apply applicable corporate procedures.
- Excellent time management skills, with the ability to prioritize workload and manage multiple tasks/projects with enthusiasm.
- Ability to lead projects and teams.
- Strong ability to analyze and interpret data.
- Attention to detail and advanced organizational skills.
- IT literate, with a strong ability to work with Microsoft-based applications and relevant Regulatory Intelligence applications such as Cortellis or Tarius.
- Proficiency in written and oral English.
-
Regulatory Intelligence Expert
hace 2 semanas
Alcobendas, Madrid, España Parexel A tiempo completoEmpowering Excellence in Regulatory IntelligenceWe are seeking a highly skilled and detail-oriented Regulatory Intelligence Specialist to contribute to our team at Parexel. As a key member of our Regulatory Intelligence team, you will be responsible for ensuring that our organization stays up-to-date with regulatory updates and implements relevant...
-
Regulatory Affairs Specialist
hace 4 semanas
Alcobendas, Madrid, España Precision Medicine Group A tiempo completoRegulatory Manager Job DescriptionPrecision for Medicine is seeking a highly skilled Regulatory Manager to provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, and submissions to Regulatory Authorities and/or Ethics Committees.Key Responsibilities:Develop and implement regulatory strategies to ensure...
-
Regulatory Affairs Specialist
hace 4 semanas
Alcobendas, Madrid, España Precision Medicine Group A tiempo completoRegulatory Manager Job DescriptionPrecision for Medicine is seeking a highly skilled Regulatory Manager to provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, and submissions to Regulatory Authorities and/or Ethics Committees.Key Responsibilities:Develop and implement regulatory strategies to ensure...
-
Business Intelligence Specialist
hace 2 semanas
Alcobendas, Madrid, España Montarelo Consulting A tiempo completoAbout the Role:We are seeking a highly skilled Business Intelligence Specialist to join our team at Montarelo Consulting. As a Business Intelligence Specialist, you will be responsible for designing, testing, and implementing business intelligence solutions, as well as fixing existing ones.Key Responsibilities:Project Lead: Work as the project lead to...
-
Regulatory Affairs Specialist
hace 4 semanas
Alcobendas, Madrid, España Precision Medicine Group A tiempo completoRegulatory Manager Job DescriptionPrecision Medicine Group is seeking a highly skilled Regulatory Manager to join our team. As a key member of our regulatory affairs team, you will play a critical role in ensuring the timely preparation and submission of high-quality regulatory documents to regulatory authorities and ethics committees.Key...
-
Regulatory Affairs Specialist
hace 4 semanas
Alcobendas, Madrid, España Precision Medicine Group A tiempo completoRegulatory Manager Job DescriptionPrecision Medicine Group is seeking a highly skilled Regulatory Manager to join our team. As a key member of our regulatory affairs team, you will play a critical role in ensuring the timely preparation and submission of high-quality regulatory documents to regulatory authorities and ethics committees.Key...
-
Regulatory Affairs Specialist
hace 2 meses
Alcobendas, Madrid, España Precision Medicine Group A tiempo completoRegulatory ManagerPrecision Medicine Group is seeking a highly skilled Regulatory Manager to join our team. As a Regulatory Manager, you will play a critical role in ensuring the timely preparation of well-organized, quality regulatory submissions in compliance with applicable regulations.Key Responsibilities:Provide regulatory strategy and development...
-
Regulatory Affairs Specialist
hace 2 meses
Alcobendas, Madrid, España Precision Medicine Group A tiempo completoRegulatory ManagerPrecision Medicine Group is seeking a highly skilled Regulatory Manager to join our team. As a Regulatory Manager, you will play a critical role in ensuring the timely preparation of well-organized, quality regulatory submissions in compliance with applicable regulations.Key Responsibilities:Provide regulatory strategy and development...
-
Regulatory Affairs Specialist
hace 1 mes
Alcobendas, Madrid, España Precision Medicine Group A tiempo completoRegulatory Manager Job DescriptionPrecision Medicine Group is seeking a highly skilled Regulatory Manager to join our team. As a key member of our regulatory affairs team, you will be responsible for providing regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric...
-
Regulatory Affairs Specialist
hace 1 mes
Alcobendas, Madrid, España Precision Medicine Group A tiempo completoRegulatory Manager Job DescriptionPrecision Medicine Group is seeking a highly skilled Regulatory Manager to join our team. As a key member of our regulatory affairs team, you will be responsible for providing regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric...
-
Regulatory Affairs Specialist
hace 2 semanas
Alcobendas, Madrid, España Precision Medicine Group A tiempo completoJob Summary:Precision Medicine Group is seeking a highly skilled Regulatory Manager to join our team. As a Regulatory Manager, you will be responsible for providing regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures.Key...
-
Regulatory Affairs Specialist
hace 3 semanas
Alcobendas, Madrid, España Precision Medicine Group A tiempo completoRegulatory Manager Job DescriptionPrecision Medicine Group is seeking a highly skilled Regulatory Manager to join our team. As a key member of our regulatory affairs team, you will be responsible for providing strategic guidance and support to ensure the timely preparation and submission of high-quality regulatory documents to regulatory authorities and...
-
Global Regulatory Acceleration Specialist
hace 7 días
Alcobendas, Madrid, España Parexel A tiempo completoUnlocking Global Market PotentialAt Parexel, we're committed to accelerating time to filing and approval in key markets. As a skilled Regulatory Affairs professional, you'll play a pivotal role in our dynamic global acceleration client initiative for late-stage phase III assets.We're seeking experienced Regulatory Affairs experts to join our team in support...
-
Business Intelligence Specialist
hace 4 semanas
Alcobendas, Madrid, España Montarelo Consulting A tiempo completoJob Title: Business Intelligence ConsultantMontarelo Consulting is seeking a highly skilled Business Intelligence Consultant to join our team in Madrid. As a Business Intelligence Consultant, you will be responsible for designing, testing, and implementing business intelligence solutions, as well as fixing existing ones.About the CompanyOur customer is a...
-
Business Intelligence Specialist
hace 4 semanas
Alcobendas, Madrid, España Montarelo Consulting A tiempo completoJob Title: Business Intelligence ConsultantMontarelo Consulting is seeking a highly skilled Business Intelligence Consultant to join our team in Madrid. As a Business Intelligence Consultant, you will be responsible for designing, testing, and implementing business intelligence solutions, as well as fixing existing ones.About the CompanyOur customer is a...
-
Senior Regulatory Affairs Specialist
hace 2 semanas
Alcobendas, Madrid, España Parexel A tiempo completoUnlock Your Expertise in Regulatory Affairs with ParexelParexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule. As a recognized professional in your field of expertise, you will...
-
Medical Device Regulatory Affairs Specialist
hace 1 mes
Alcobendas, Madrid, España Parexel A tiempo completoJob Title: Medical Device Regulatory Affairs LeadWe are seeking a highly skilled Medical Device Regulatory Affairs Lead to join our team at Parexel. As a key member of our regulatory affairs team, you will be responsible for overseeing key regulatory activities and providing strategic and tactical support on combination product portfolios.Key...
-
Medical Device Regulatory Affairs Specialist
hace 1 mes
Alcobendas, Madrid, España Parexel A tiempo completoJob Title: Medical Device Regulatory Affairs LeadWe are seeking a highly skilled Medical Device Regulatory Affairs Lead to join our team at Parexel. As a key member of our regulatory affairs team, you will be responsible for overseeing key regulatory activities and providing strategic and tactical support on combination product portfolios.Key...
-
Senior Regulatory Affairs Specialist
hace 2 semanas
Alcobendas, Madrid, España Parexel A tiempo completoAccelerating Time to Filing and ApprovalParexel is seeking an experienced Regulatory Affairs professional to join our dynamic team in support of a global acceleration client initiative for late-stage phase III assets. This is an exciting opportunity to play a crucial role in accelerating time to filing and approval in Global Country Initiative (GCI),...
-
Business Intelligence Solutions Designer
hace 4 semanas
Alcobendas, Madrid, España Montarelo Consulting A tiempo completoJob Title: Business Intelligence ConsultantCompany: Montarelo ConsultingLocation: Madrid, European UnionJob Type: Full-timeSalary: Competitive salary packageJob Description:Job SummaryWe are seeking an experienced Business Intelligence Consultant to join our team. As a Business Intelligence Consultant, you will be responsible for designing, testing, and...
