Huidige banen gerelateerd aan Senior Regulatory Specialist - Breda, Noord-Brabant - Scendea
-
Senior Regulatory Consultant
5 dagen geleden
Breda, Noord-Brabant, Nederland Scendea VoltijdJob DescriptionWe are seeking a highly motivated Senior Regulatory Consultant to join our global team. This is a hybrid position, affiliated to our Netherlands office, with a requirement to work in the office a minimum of one day per month.This is an excellent opportunity to progress your career at a rapidly growing Regulatory Consultancy. You will have the...
-
Senior Regulatory Affairs Specialist
7 dagen geleden
Breda, Noord-Brabant, Nederland Scendea VoltijdJob OverviewScendea is an international product development and regulatory consulting group delivering market-leading scientific expertise & regulatory solutions, to advance healthcare innovation worldwide. Our goal is to streamline the product development process, reduce time-to-market, and minimise overall development costs.We are seeking a highly...
-
Regulatory Affairs Specialist
3 dagen geleden
Breda, Noord-Brabant, Nederland Scendea VoltijdJob DescriptionWe are seeking a highly motivated Regulatory Affairs Specialist to join our global team. The successful candidate will have a strong background in drug development and regulatory affairs, with experience in working with FDA, EMA, and/or MHRA submissions.The ideal candidate will have a high level of technical knowledge in product development...
-
Senior Regulatory Consultant
3 dagen geleden
Breda, Noord-Brabant, Nederland Scendea VoltijdCompany OverviewScendea is a global regulatory consulting group delivering market-leading scientific expertise & regulatory solutions to advance healthcare innovation worldwide. We are passionate about delivering strategic and operational support to clients with a strong commitment to problem-solving and redefining customer service.We have a current team of...
-
Regulatory Expertise Senior Manager
7 dagen geleden
Breda, Noord-Brabant, Nederland Scendea VoltijdScendea is a leading international product development and regulatory consulting group. Our team of experts delivers market-leading scientific expertise & regulatory solutions to advance healthcare innovation worldwide.About the RoleWe are seeking a highly motivated individual to join our global team as a full-time Principal Consultant (CMC). This hybrid...
-
Regulatory Affairs Specialist
4 uur geleden
Breda, Noord-Brabant, Nederland Scendea VoltijdCompany OverviewScendea is an international product development and regulatory consulting group delivering market-leading scientific expertise & regulatory solutions to advance healthcare innovation worldwide.We are passionate about delivering strategic and operational support to clients, with a strong commitment to problem-solving and redefining customer...
-
Global CMC Specialist
5 dagen geleden
Breda, Noord-Brabant, Nederland Scendea VoltijdYour Role and ResponsibilitiesAs a Senior Regulatory Consultant, you will be responsible for:Providing expert regulatory advice and guidance to clients on CMC development of human medicinal products.Liaising with internal teams to ensure seamless delivery of consulting services.Developing and maintaining relationships with clients, identifying opportunities...
-
Senior Consultant
4 weken geleden
Breda, Noord-Brabant, Nederland Scendea VoltijdThe RoleScendea is seeking a highly motivated individual to join our global team as a full-time Senior Consultant (CMC). This is a hybrid position, affiliated to our Netherlands office, with a requirement to work in the office a minimum of one day per month.This is an excellent opportunity to progress your career at a rapidly growing Regulatory Consultancy....
-
Senior Consultant
3 weken geleden
Breda, Noord-Brabant, Nederland Scendea VoltijdThe RoleScendea is seeking a highly motivated individual to join our global team as a full-time Senior Consultant (CMC). This is a hybrid position, affiliated to our Netherlands office, with a requirement to work in the office a minimum of one day per month.This is an excellent opportunity to progress your career at a rapidly growing Regulatory Consultancy....
-
Senior Pharmaceutical Consultant
5 dagen geleden
Breda, Noord-Brabant, Nederland Scendea VoltijdAbout the RoleWe are seeking a highly skilled Senior Pharmaceutical Consultant to join our team as a full-time Principal Consultant (CMC). This is a hybrid position, affiliated with our office in Breda, Netherlands, with a requirement to work in the office a minimum of one day per month.This is an excellent opportunity to progress your career at a rapidly...
-
Senior CMC Professional
5 dagen geleden
Breda, Noord-Brabant, Nederland Scendea VoltijdAbout Us:Scendea is an international product development and regulatory consulting group delivering market-leading scientific expertise & regulatory solutions, to advance healthcare innovation worldwide. We are passionate about delivering strategic and operational support to clients, with a strong commitment to problem-solving and redefining customer...
-
Senior Commercial Account Executive
1 week geleden
Breda, Noord-Brabant, Nederland QbD Group VoltijdSenior Account Manager Netherlands The QbD Group supports life sciences companies worldwide from idea to patient. QbD's team offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in ATMP, Biotech, Medical Devices, In Vitro Diagnostics, Digital Health and Pharma. ...
-
Senior Business Development Manager Netherlands
4 uur geleden
Breda, Noord-Brabant, Nederland QbD Group VoltijdSenior Business Development Manager Netherlands\The QbD Group is a global life sciences company that supports organizations from idea to patient. Our team offers tailored solutions in development, clinical, regulatory & compliance, production, and distribution for companies active in ATMP, Biotech, Medical Devices, In Vitro Diagnostics, Digital Health, and...
-
Senior Finance Specialist
7 dagen geleden
Breda, Noord-Brabant, Nederland Camping Vision Voltijd € 3.500 - € 3.800Camping Vision is a fast-growing provider of holidays at campsites and holiday parks in Europe. We are looking for a skilled Procurement Process Manager to join our finance team in Northern Europe.As a Senior Finance Specialist, you will be responsible for one of our most important purchasing and payment processes, namely that of our camping partners. You...
-
Life Sciences Business Development Specialist
4 uur geleden
Breda, Noord-Brabant, Nederland QbD Group VoltijdThe QbD Group is a global life sciences company supporting companies from idea to patient. Our team offers knowledge and tailored solutions in development, clinical, regulatory, and compliance for companies active in ATMP, Biotech, Medical Devices, In Vitro Diagnostics, Digital Health, and Pharma.We have affiliates in 8 countries and over 600 life science...
-
English Consultant
2 weken geleden
Breda, Noord-Brabant, Nederland Scendea VoltijdScendea is seeking a highly motivated individual to join our global team as a full-time Senior Consultant (CMC). This is a hybrid position, affiliated to our Netherlands office, with a requirement to work in the office a minimum of one day per month. This is an excellent opportunity to progress your career at a rapidly growing Regulatory Consultancy. You...
-
Psychiater Senioren
5 dagen geleden
Breda, Noord-Brabant, Nederland GGz Breburg VoltijdWat ga je doen? Je stelt als psychiater bij team Ambulant Senioren Breda behandelindicaties op en zorgt voor bespreking hiervan in het behandelteam. Je verricht medicamenteuze behandelingen. Je werkt volgens multidisciplinaire richtlijnen. Je werkt actief mee aan de ontwikkeling van het behandelbeleid. Je bent als psychiater...
-
Senior Accounts Payable Specialist
7 dagen geleden
Breda, Noord-Brabant, Nederland Camping Vision VoltijdWe are looking for a passionate and enthusiastic Senior Accounts Payable Specialist In our finance team, which is responsible for Northern Europe, you will work with fifteen colleagues spread across multiple locations throughout the country. You will work 40 hours a week from our office in Breda. You will have a fun and varied job in a professional company...
-
Senior Key Accountmanager
2 weken geleden
Breda, Noord-Brabant, Nederland Howden VoltijdVind jij het belangrijk om als Senior Accountmanager Business Professionals dé adviseur en relatiebeheerder te zijn voor onze specifieke klanten in de doelgroep business professionals (Dan is de Senior Accountmanager Business Professionals rol helemaal voor jou Howden, is dé specialist als het gaat om advisering van Business Professionals (Accountants,...
-
Senior Beleidadviseur Ruimte
7 dagen geleden
Breda, Noord-Brabant, Nederland Maandag VoltijdWe zoeken een Ruimtelijke Ordening Specialist die als Senior Beleidsmedewerker aan de slag gaat bij de Gemeente Breda. In deze rol word je verantwoordelijk voor het adviseren van beleidmakers op het gebied van ruimtelijke ordening.Functie- en takenomschrijvingHet is jouw taak om strategische plannen te ontwikkelen die inzetten op duurzame ontwikkeling van...
Senior Regulatory Specialist
2 weken geleden
Scendea is a leading international product development and regulatory consulting group, dedicated to delivering market-leading scientific expertise & regulatory solutions. We are passionate about delivering strategic and operational support to clients, with a strong commitment to problem-solving and redefining customer service.
Job Description
We seek a highly motivated individual to join our global team as a full-time Principal Consultant (CMC). This is a hybrid position, affiliated to our Breda office, with a requirement to work in the office a minimum of one day per month. The successful candidate will have the opportunity to play a key role in the development and mentoring of staff whilst providing high-quality regulatory technical advice and product development strategies for clients.
Key responsibilities include:
* Providing strategic, technical and regulatory advice/services to clients with a special interest in CMC development of human medicinal products.
* Developing innovative drug development plans, data gap analyses and international regulatory strategies from a CMC perspective for complex products within the changing regulatory environment.
* Contributing to technical authorship and review of development regulatory documents including Regulatory Strategy Plans, Drug Development Plans, Clinical Trial Applications, Pre-INDs, INDs, Scientific Advice and Meeting Briefing Documents, Paediatric plans/applications, Investigator Brochures, IMPDs, Marketing Authorisation Applications, New Drug Applications, Biologic License Applications, DMFs according to area of expertise.
* Leading multi-jurisdiction programs of work and delivering consulting services within your respective area of expertise.
* Leading meetings with internal and external stakeholders on matters related to any current and/or future projects, contracts, or new business opportunities.
* Supporting Scendea's Business Development in sales/marketing introductions and generating additional business from current clients.
* Line managing, training, and mentoring members of the Scendea Operational team, including providing technical leadership.
Requirements
A high scientific calibre with a relevant science focused BSc (or equivalent), and a higher degree in a biomedical field or equivalent (e.g., a life/physical science focused MSc or preferably a PhD). Direct experience preferred in providing strategic regulatory planning from early-stage development up to marketing authorisation, and a proven ability to define and deliver creative scientifically driven solutions to technical development and regulatory issues. Proven ability and willingness to lead a team and deliver education and training in chosen field, both internally, and at scientific conference presentations.
