Huidige banen gerelateerd aan Principal Consultant - Breda - Scendea
-
Principal Regulatory Advisor
6 dagen geleden
Breda, Noord-Brabant, Nederland Scendea VoltijdYour Role:As a Principal Consultant (CMC), you will be responsible for providing high-quality regulatory technical advice and product development strategies to clients. You will also play a key role in the development and mentoring of staff, while contributing to technical authorship and review of development regulatory documents. Additionally, you will be...
-
Principal 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 Principal Consultant (CMC). This is a hybrid position, affiliated to our Breda, 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...
-
Principal Consultant
2 weken geleden
Breda, Noord-Brabant, Nederland Scendea VoltijdThe RoleScendea is seeking 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, 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...
-
Principal Consultant
2 weken geleden
Breda, Noord-Brabant, Nederland Scendea VoltijdThe Role Scendea is seeking 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, 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...
-
Procurement & Customs Specialist - Orffa Additives BV
7 dagen geleden
Breda, Noord-Brabant, Nederland VONQ VoltijdBreda | Supply Chain | Agriculture | Hbo | In dienst bij opdrachtgever Kim Steenkamp | Principal Consultant . Solliciteer direct op deze vacature Direct solliciteren Solliciteren kan al binnen 2 minutenVacature nummer: V Over deze vacatureWil jij een veelzijdige...
-
Procurement & Customs Specialist - Orffa Additives BV
3 dagen geleden
Breda, Noord-Brabant, Nederland VONQ VoltijdBreda | Supply Chain | Agriculture | Hbo | In dienst bij opdrachtgever Kim Steenkamp | Principal Consultant . Solliciteer direct op deze vacature Direct solliciteren Solliciteren kan al binnen 2 minutenVacature nummer: V Over deze vacature Wil jij een veelzijdige...
-
Logistics & Customer Excellence Manager - Orffa Additives BV
7 dagen geleden
Breda, Noord-Brabant, Nederland VONQ VoltijdBreda | Directie & Management | Agriculture | Hbo | In dienst bij opdrachtgever Kim Steenkamp | Principal Consultant | Direct solliciteren Solliciteren kan al binnen 2 minuten Vacature nummer: V Over deze vacature Ben jij een gedreven logistiek professiona...
-
Regulatory Expert Consultant
2 dagen geleden
Breda, Noord-Brabant, Nederland Scendea VoltijdJob OverviewAs a Principal Consultant (CMC) at Scendea, you will play a key role in the development and mentoring of staff while providing high-quality regulatory technical advice and product development strategies for clients. Your expertise in CMC development of human medicinal products will be invaluable to our global team.Responsibilities:Provide...
-
Principal Consultant
4 weken geleden
Breda, North Brabant, Netherlands, NL Scendea VoltijdThe RoleScendea is seeking 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, 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...
-
Procurement Specialist voor Additieven
2 dagen geleden
Breda, Noord-Brabant, Nederland VONQ VoltijdBekijk deze vacature van Procurement & Customs Specialist en leer meer over de taken, verantwoordelijkheden en de toekomstperspectieven binnen de organisatie VONQ.OverzichtBreda is een unieke stad gelegen aan de Nieuwe Maas, waarVONQ is een belangrijke speler op het gebied van Agriculture. In dienst bij opdrachtgever Kim Steenkamp, werken wij als Principal...
-
Procurement & customs specialist - orffa additives bv
6 dagen geleden
Breda, Noord-Brabant, Nederland ORFFA VoltijdBreda | Supply Chain | Agriculture | Hbo | In dienst bij opdrachtgever Kim Steenkamp | Principal Consultant. Solliciteer direct op deze vacature Direct solliciteren Solliciteren kan al binnen 2 minuten Vacature nummer: V-20042410 Over deze vacature Wil jij een veelzijdige functie in een dynamische internationale omgeving? Heb je ervaring met inkoop en...
-
Procurement & Customs Specialist - Orffa Additives Bv
3 dagen geleden
Breda, Noord-Brabant, Nederland ORFFA VoltijdBreda | Supply Chain | Agriculture | Hbo | In dienst bij opdrachtgever Kim Steenkamp | Principal Consultant.Solliciteer direct op deze vacature Direct solliciteren Solliciteren kan al binnen 2 minuten Vacature nummer: V-20042410 Over deze vacature Wil jij een veelzijdige functie in een dynamische internationale omgeving? Heb je ervaring met inkoop en...
-
Procurement & Customs Specialist - Orffa Additives BV
4 dagen geleden
Breda, Noord-Brabant, Nederland ORFFA VoltijdBreda | Supply Chain | Agriculture | Hbo | In dienst bij opdrachtgeverKim Steenkamp | Principal Consultant. Solliciteer direct op deze vacatureDirect solliciteren Vacature nummer: VOver deze vacatureWil jij een veelzijdige functie in een dynamische internationale omgeving? Heb je ervaring met inkoop en affiniteit met douaneprocessen? Dan is deze functie bij...
-
Procurement & Customs Specialist - Orffa Additives Bv
2 dagen geleden
Breda, Noord-Brabant, Nederland ORFFA VoltijdTaken en verantwoordelijkheden Breda | Supply Chain | Agriculture | Hbo | In dienst bij opdrachtgever Kim Steenkamp | Principal Consultant.Solliciteer direct op deze vacature Direct solliciteren Solliciteren kan al binnen 2 minuten Vacature nummer: V-20042410 Over deze vacature Wil jij een veelzijdige functie in een dynamische internationale omgeving? Heb...
-
Logistiek en Klant Excellence Manager
7 dagen geleden
Breda, Noord-Brabant, Nederland VONQ VoltijdVanuit VONQ, ons team werkt als principal consultant aan projecten voor opdrachtgevers. Voor onze opdrachtgever Orffa Additives BV, in Breda, zijn wij op zoek naar een gedreven manager met expertise in logistiek en klantenservice.Informatie over de functieAls Logistics & Customer Excellence Manager werk je mee aan het optimaliseren van onze interne processen...
-
Regulatory Technical Advisor
5 dagen geleden
Breda, Noord-Brabant, Nederland Scendea VoltijdJob Description:We are seeking a highly motivated individual to join our global team as a full-time Principal Consultant (CMC). This hybrid position is affiliated with our Breda, Netherlands office and requires working in the office at least one day per month. The successful candidate will play a key role in the development and mentoring of staff while...
-
Procurement & Customs Specialist - Orffa Additives BV
1 week geleden
Breda, Noord-Brabant, Nederland ORFFA VoltijdBreda | Supply Chain | Agriculture | Hbo | In dienst bij opdrachtgeverKim Steenkamp | Principal Consultant. Solliciteer direct op deze vacatureDirect solliciterenSolliciteren kan al binnen 2 minutenVacature nummer: V-20042410Over deze vacatureWil jij een veelzijdige functie in een dynamische internationale omgeving? Heb je ervaring met inkoop en affiniteit...
-
Regulatory Expert Consultant
7 dagen geleden
Breda, Noord-Brabant, Nederland Scendea VoltijdJob Description:We are seeking a highly skilled Principal Consultant (CMC) to join our team. As a key member of our global consulting group, you will play a vital role in delivering high-quality regulatory technical advice and product development strategies to clients.The ideal candidate will have a strong scientific background, with a relevant degree in a...
-
English Consultant
1 week geleden
Breda, Noord-Brabant, Nederland Scendea VoltijdScendea is seeking 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, 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...
-
Breda, Noord-Brabant, Nederland ORFFA VoltijdBreda | Directie & Management | Agriculture | Hbo | In dienst bij opdrachtgever Kim Steenkamp | Principal Consultant | Direct solliciteren Solliciteren kan al binnen 2 minuten Vacature nummer: V-20042409 Over deze vacature Ben jij een gedreven logistiek professional met een passie voor internationale handel en transport? Heb jij ervaring in de...
Principal Consultant
1 maand geleden
The Role
Scendea is seeking 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, 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 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.
Role Requirements
- Provide strategic, technical and regulatory advice/services to clients with a special interest in CMC development of human medicinal products.
- Establish and maintain a high level of technical knowledge in product development and international regulatory affairs.
- Provide innovative drug development plans, data gap analyses and international regulatory strategies from a CMC perspective for complex products within the changing regulatory environment.
- Contribute 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.
- Lead multi-jurisdiction programs of work and deliver consulting services within your respective area of expertise.
- Represent clients in regulatory agency interactions and provide regulatory solutions to agency objections.
- Ensure delivery of project goals within agreed timelines, maintaining oversight of project budgets.
- Lead meetings with internal and external stakeholders on matters related to any current and/or future projects, contracts, or new business opportunities.
- Support Scendea's Business Development in sales/marketing introductions and generate additional business from current clients.
- Line manage, train, and mentor members of the Scendea Operational team, including providing technical leadership.
Skills and Experience
- 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).
- A minimum of ten years of drug development experience.
- A minimum of ten years of regulatory experience, working with either FDA, EMA, and/or MHRA submissions, including meetings/negotiation. Regulatory experience may include time within a National Competent Authority.
- Demonstrated experience with a broad range of products, including recombinant proteins and peptides (including antibodies), prophylactic and therapeutic vaccines, biosimilar products, advanced therapy medicinal products (tissue, cell and gene therapy), RNA or DNA based products, live biotherapeutics and small molecule NCE and/or generic chemical entities.
- 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.
- Exemplary organisational and time management skills with a high level of attention to detail, and the proven ability to work both proactively and autonomously.
- High level of verbal communication and presentation skills in English, computer literacy, and competency in MS Office programs.
- Willingness to work flexible hours and travel for short periods, sometimes at short notice, within the country of employment, or internationally.
Benefits
- A competitive salary.
- Generous bonus program, which rewards success.
- 26 days’ vacation plus discretionary additional days for birthday and work anniversary and public holidays.
- Employer pension contribution/ compensation in line with country specific legislation.
- Compensation of Private Healthcare insurance.
- Access to Employee Assistance Programme.
- Employee Ownership Trust Scheme.
- A challenging and stimulating position for a dynamic and competent scientist, looking to contribute to a growing business and a rapidly expanding team.
- Coaching, mentoring and support of your continuous learning, and professional development within a highly recognised international team.
The Company
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 service. Our goal is to streamline the product development process, reduce time-to-market, and minimise overall development costs.
With a current team of over 50 staff based in the UK, Netherlands, Australia, and the US, Scendea is undergoing a period of significant growth, with the addition of new office locations and service lines to facilitate the delivery of expert and strategic global regulatory consulting services to our rapidly growing client base. We are equally committed to making a positive impact on society by managing our environmental impacts and contributing to a low-carbon economy. Our inclusive work culture values transparency, ethical collaboration with clients, and employee involvement in key decision-making processes, ensuring that our team is respected, supported, and engaged.
As a Scendea Employee
Part of what makes Scendea successful is the highly motivated people who work for us and their enthusiasm for what we do and stand for. We recruit individuals whose passion, drive, integrity and customer orientation shines through. You are a motivated individual who can instil trust and confidence in our customer relationships whilst having a natural aptitude for getting the best out of people internally. You will inspire others through your commitment, motivation, expertise, professional manner and always placing the customer at the centre of everything you do.
Eligibility & Conditions
Applicants must reside and be eligible to work in The Netherlands without the requirement for sponsorship now or in the future. Closing date for applications is Monday 10th February 2025 and candidates will be notified by of the outcome of their application no later than Friday 14th February 2025.
