Regulatory Manager
Encontrado en: Talent ES C2 - hace 1 semana
Precision for Medicine (CRO) are recruiting a Regulatory Manager to join our team, candidates can be based in the following countries: UK, Spain, Hungary, Slovakia, Serbia, Romania or Poland.
Position Summary:
The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. The RM coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable. The RM maintains a current knowledge of regulations and guidance documents, providing analysis to project teams, as well as supporting and enhancing Precision for Medicines corporate Regulatory function.
Essential functions of the job include but are not limited to:
Provides regulatory guidance throughout the clinical development life cycleCompile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications. Also provides strategic regulatory input as requiredDevelops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standardsServe as representative of Global Regulatory Affairs at project team meetings with both external and internal customersWorks within a project team, and where necessary, leads project for the region or globallyOversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programsMaintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.Assist in development of Regulatory Affairs Specialists and other operational area staff, as requiredProvide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted informationParticipates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions.Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approvalProvides ICH GCP guidance, advice and training to internal and external clientsServe as representative of Global Regulatory Affairs at business development meetingsQualifications:
Minimum Required:
Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline 5 years Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level Computer literacy (MS Office/ Office 365)Fluent in EnglishPreferred:
Graduate, postgraduatePossesses basic understanding of financial managementOther Required:
Candidates must have regulatory affairs experience working for a Clinical Research Organisation and have experience leading Clinical Submissions
Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones and specialized knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions.
Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategyKnowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studiedKnowledge and expertise with relevant regulations and guidance supporting pharmaceutical developmentAvailability for domestic and international travel including overnight staysCompetencies
Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from multifaceted research activitiesDemonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammatesAbility to manage multiple and varied tasks in a fast-moving environment, good record-keeping skillsExhibits high self-motivation, and is able to work and plan independently as well as in a team environmentMotivates other members of the project team to meet timelines and project goalsFlexible attitude with respect to work assignments, and new learningResolves project related problems and prioritize workload to meet deadlines with little support from managementFocuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effectiveCollects data of consistently high standardCommunicates effectively in the English language both verbally and in written formConducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency#LI-NC1 #LI-Remote
-
Regulatory Manager
hace 1 semana
Alcobendas, España Sdi Digital Group A tiempo completoWhen our values align, there's no limit to what we can achieve. Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various European...
-
Audit/Compliance Analyst
Encontrado en: Talent ES C2 - hace 2 semanas
Alcobendas, España VASS A tiempo completoDescripción Job Family Description: • Monitors activities to minimize the company's exposure to third party risk. • Activities may include vendor management system administration, service manager support, third party assessments, risk identification and remediation. • Represents or supports the reputation of the company to minimize...
-
Clinical Trial Manager
Encontrado en: Talent ES C2 - hace 1 semana
Alcobendas, España Precision Medicine Group A tiempo completoWe have current opportunity for an experienced Clinical Trial Manager in Europe! Join our growing team.Precision for Medicine is a precision medicine CRO. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data...
-
Health & Safety Manager
hace 6 días
Alcobendas, España DATA4 Group A tiempo completoABOUT THE ROLE They are responsible for the implementation of the “Construction, Fit Out and Ops” H&S programs locally in relation with all relevant stakeholders, in particular with the «Construction, Fit Out and OPS» teams, to develop a real H&S culture, to meet the group H&S objectives in compliance with all applicable regulations and within the...
-
Senior Clinical Data Manager
hace 2 semanas
Alcobendas, España Sdi Digital Group A tiempo completoAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Technical Infrastructure Program Manager, Building Management System
Encontrado en: beBee S ES - hace 3 semanas
Alcobendas, España Amazon Spain Services, S.L.U. - B76 A tiempo completoAt Amazon, we believe that Every Day is still Day One! We’re working to be the most customer-centric company on earth. To get there, we need exceptionally talented, bright and driven people. Amazon’s Reliability, Maintenance, and Engineering organization (RME) is hiring a Technical Infrastructure Program Manager focused on Building Management Systems...
-
Principal Medical Writer, sponsor-dedicated, EMEA
Encontrado en: Talent ES C2 - hace 2 semanas
Alcobendas, España Fortrea A tiempo completoAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Senior Product Manager
Encontrado en: Talent ES C2 - hace 2 semanas
Alcobendas, España dLocal A tiempo completoWhy you should join dLocal? dLocal enables the biggest companies in the world to collect payments in 40 countries in emerging markets. Global brands rely on us to increase conversion rates and simplify payment expansion effortlessly. As both a payments processor and a merchant of record where we operate, we make it possible for our merchants to make inroads...
-
Clinical Trial Leader
hace 2 semanas
Alcobendas, España Sdi Digital Group A tiempo completoWhen our values align, there's no limit to what we can achieve. When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep...
-
Clinical Trial Leader
Encontrado en: Talent ES C2 - hace 1 semana
Alcobendas, España Parexel A tiempo completoWhen our values align, there's no limit to what we can achieve. When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something...
-
Senior Statistical SAS Programmer, Oncology, Single Sponsor
Encontrado en: Talent ES C2 - hace 1 semana
Alcobendas, España Fortrea A tiempo completoAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Senior Statistical Programmer, Single Sponsor
Encontrado en: Talent ES C2 - hace 1 semana
Alcobendas, España Fortrea A tiempo completoAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Alcobendas, España Institut Straumann Ag A tiempo completoAbout Straumann Group: Headquartered in Basel, Switzerland, the Straumann Group stands at the pinnacle of dental innovation, with a reach spanning more than 100 countries worldwide. We pride ourselves on our expansive network of distribution subsidiaries and partners, showcasing global brands such as Straumann, Neodent, Medentika, DR SMILE, TeethToday, and...
-
Finance Business Partner Global E2E Supply Chain
Encontrado en: beBee jobs ES - hace 3 semanas
Alcobendas, Madrid, España Straumann A tiempo completoAbout Straumann Group: Headquartered in Basel, Switzerland, the Straumann Group stands at the pinnacle of dental innovation, with a reach spanning more than 100 countries worldwide. We pride ourselves on our expansive network of distribution subsidiaries and partners, showcasing global brands such as Straumann, Neodent, Medentika, DR SMILE, TeethToday, and...
-
Finance Business Partner Global E2E Supply Chain
Encontrado en: beBee S ES - hace 2 semanas
Alcobendas, España Straumann A tiempo completoAbout Straumann Group: Headquartered in Basel, Switzerland, the Straumann Group stands at the pinnacle of dental innovation, with a reach spanning more than 100 countries worldwide. We pride ourselves on our expansive network of distribution subsidiaries and partners, showcasing global brands such as Straumann, Neodent, Medentika, DR SMILE, TeethToday, and...
-
Statistical Programmer
Encontrado en: Talent ES C2 - hace 2 semanas
Alcobendas, España Fortrea A tiempo completoAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
