Associate Director/Director Regulatory Affairs
il y a 3 semaines
Client: Regulatory affairs
Location: Antwerp, Belgium
Job Category: Other
EU work permit required: Yes
Job Reference: 13bd1291501e
Job Views: 26
Posted: 23.01.2025
Expiry Date: 09.03.2025
Job Description:The UK team of the international QbD group is a specialist regulatory and pharmacovigilance consultancy company. Our services consist of providing consultation throughout product development, regulatory approval, market launch, and into life cycle management. We have been offering support to life science companies for 14 years.
What do we expect from you as (Associate) Director Regulatory Affairs?
- You are part of the UK management team, leading development and growth of the company.
- You provide a full range of regulatory consulting services (strategy and writing) with an emphasis on clinical documents (overviews, briefing packages, orphan drug designations, paediatric investigation plans).
- You deliver complex projects on time and to a high quality.
- You are a source of regulatory expertise in the development, registration, and post-licensing activities of pharmaceutical products.
- You have line management responsibility and provide guidance to the QbD team across projects (training, supervising, mentoring, reviewing).
- You interact professionally at multiple levels within a client organization.
- You continue to build a network of industry colleagues. You develop and maintain personal contacts with regulatory agencies or professional associations to build confidence in and enhance the reputation of QbD.
- You assist in the preparation of proposals (researching new potential projects, determining activities required).
Who are we looking for?
- You have a university degree in life science.
- You have sound knowledge of European pharmaceutical regulations and guidelines.
- You have significant regulatory affairs experience including a successful track record in the development, registration, and life-cycle maintenance of medicinal products within Europe, in particular a strong background in the review/generation of clinical documents (overviews, briefing packages, orphan drug designations, paediatric investigation plans).
- You have excellent written and verbal communication skills and proven negotiation skills. You can establish strong connections with clients, regulators, management, and colleagues.
- You have good organizational skills and an analytical mindset.
- You enjoy working in an international environment.
- A true QbD’er can be recognized by the following qualities: Resilient: Your strong and positive attitude helps you overcome any challenge; Hungry for knowledge: You are always open to learning; No nonsense mentality: you can be straightforward in a respectful way; Innovative: You are constantly looking for new and better solutions; (Not too) serious: your job is serious, but you don’t take yourself too seriously.
What’s in it for you?
- QbD offers you an attractive and complete salary package.
- We invest in sustainable careers and meaningful connections.
- We are a knowledge based company.
- You’ll work for an international award-winning company.
- Our promise to you: As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences. Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals. In short … We stand for JPEG: Joy in Partnership, going for the Extra mile to Get things done
Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family
#J-18808-Ljbffr-
Associate Director Regulatory Affairs
il y a 3 semaines
Antwerp, Belgique TN Belgium Temps pleinSocial network you want to login/join with:Associate Director Regulatory Affairs, AntwerpClient:Regulatory affairsLocation:Antwerp, BelgiumJob Category:OtherEU work permit required:YesJob Reference:109d12980fa4Job Views:26Posted:23.01.2025Expiry Date:09.03.2025Job Description:QbD Austria, part of the international QbD group, is a young and growing consulting...
-
Senior Director of Outsourcing
il y a 6 jours
Antwerp Metropolitan Area, Belgique Planet Pharma Temps pleinOne of our exciting biotech clients are seeking a Senior Director of Outsourcing to support their work in BelgiumClientThis role is a top biotechnology company in Belgium that has grown by 98% in the past two years and recently had two products approved by the FDA. They outsource lots of their activities and are now looking to make a critical hire. Within...
-
Regulatory Compliance Associate
il y a 3 semaines
Antwerp, Belgique J&J Temps pleinRegulatory Compliance AssociateLocation: Turnhoutseweg, BeerseDuration: End of 2025 initiallyHours: 40 hours per week, on-siteImagine your next project as a Regulatory Compliance Associate, working at the forefront of cutting edge work and technology with one of the leading Pharmaceutical companies in the world!roles and responsibilitiesYou will play a key...
-
Associate Medical Director
il y a 3 semaines
Antwerp, Belgique Galapagos Temps pleinPleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in US, headquartered in Mechelen, Belgium.We are in the business of changing lives. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules,...
-
Regional Director of Regulatory Affairs and Institutional Relations
il y a 2 semaines
Antwerp, Belgique PSA Belgium Temps pleinYou will play a pivotal role in advancing PSA’s policy objectives by managing relationships with European institutions, national governments, industry associations, and other key stakeholders. Role: You will be responsible for monitoring and shaping regulatory developments, identifying and securing public funding opportunities, and supporting business...
-
Director Taxatie
il y a 3 semaines
Antwerp, Belgique WhatJobs Temps pleinActuele vacatures gerelateerd aan Director Taxatie - Antwerpen - Robert Walters Director Taxatie - Antwerpen - Robert Walters In deze rol zorg jij voor de continuïteit van het taxatieteam door ze te coachen, motiveren en delegeren. Verantwoordelijkheden: Leiden en beoordelen van teamprestaties. Controleer dossiers en rapporten voor klantoverdracht. Beheer...
-
Regulatory Affairs Specialist – Medical Devices
il y a 3 semaines
Antwerp, Belgique TN Belgium Temps pleinRegulatory Affairs Specialist – Medical Devices, AntwerpClient:Regulatory affairsLocation:Antwerp, BelgiumJob Category:OtherEU work permit required:YesJob Reference:e8c73abab4dbJob Views:61Posted:23.01.2025Expiry Date:09.03.2025Job Description:At QbD, our RA Services go from regulatory strategy, clinical, technical file to Vigilance. We support from idea...
-
Director Taxatie
il y a 3 semaines
Antwerp, Belgique Robert Walters Temps pleinActuele vacatures gerelateerd aan Director Taxatie - Antwerpen - Robert WaltersDirector Taxatie - Antwerpen - Robert WaltersIn deze rol zorg jij voor de continuïteit van het taxatieteam door ze te coachen, motiveren en delegeren.Verantwoordelijkheden:Leiden en beoordelen van teamprestaties.Controleer dossiers en rapporten voor klantoverdracht.Beheer...
-
Regulatory Affairs and Quality Assurance Vice President
il y a 3 semaines
Antwerp, Belgique Nipro Europe Group Temps pleinRegulatory Affairs and Quality Assurance Vice President - Mechelen - Nipro Europe GroupThe Vice President of Regulatory Affairs, Clinical Affairs, and Quality Assurance will lead the RA/QA/CA team within Nipro Medical Europe, ensuring compliance with quality and regulatory requirements for medical devices.This role is responsible for ensuring that NME and...
-
Director Accountancy
il y a 3 semaines
Antwerp, Belgique CareerWallet Temps pleinCrowe Spark: een werkplek waar JIJ centraal staat Sterke expertise, een digitale groeimindset en ruim 25 jaar ervaring in binnen én buitenland: Crowe Spark, aangenaam! Als accountancy- en adviesbureau in Antwerpen, Mechelen en Bornem servicen we een brede waaier van ambitieuze kmo's en bedrijven. Dat doen we met een gespecialiseerd dienstenaanbod, een...
-
Finance Director
il y a 3 semaines
Antwerp, Belgique TN Belgium Temps pleinVandaag bestaat 62MILES uit 6 gelauwerde agencies: mortierbrigade (integrated communications), Fantastic (employer branding), Onlyhumans (online content & performance), Today (branding), Who Owns The Zebra (digital studio), meetmarcel (live experiences), samen alvast talenten die 45 miljoen omzet realiseren vanuit hun hoofdkwartier in Berchem en kantoren in...
-
M&A VP/Director
il y a 1 semaine
Antwerp Metropolitan Area, Belgique Selby Jennings Temps pleinM&A VP/Director – Antwerp - Dutch SpeakingLocation: Antwerp, BelgiumExperience: 7+ Years in M&AAre you an experienced M&A professional with a proven ability to originate and execute deals? Our client, a leading financial advisory firm, is seeking a Vice President or Director to join their growing dynamic M&A team in Antwerp. This is a unique opportunity to...
-
IT Director
il y a 2 semaines
Antwerp, Belgique Infinitek Limited Temps pleinInfinitek Group are working with a leading global Business Solutions company supporting a privately held portfolio of multinational businesses in building products manufacturing and affiliated industries. Today, their fusion process helps drive growth for companies in distribution, transportation, real estate, construction, agriculture and more. They are...
-
Director Asset Management
il y a 3 semaines
Antwerp, Belgique WhatJobs Temps pleinUitdagende functie bij ontwikkelaar met een high-end portfolio Werken op directieniveau bij kapitaalkrachtige ontwikkelaar Over onze klant Director Asset Management - High-End Ontwikkelaar Als kapitaalkrachtige ontwikkelaar van hoogstaande projecten, zijn ze al 30 jaar bekend binnen het Antwerpse en nu ook internationaal. De bedrijfscultuur is vlak en...
-
Director Asset Management
il y a 3 semaines
Antwerp, Belgique Michael Page International (Belgium) Temps pleinUitdagende functie bij ontwikkelaar met een high-end portfolioWerken op directieniveau bij kapitaalkrachtige ontwikkelaar Over onze klant Director Asset Management - High-End OntwikkelaarAls kapitaalkrachtige ontwikkelaar van hoogstaande projecten, zijn ze al 30 jaar bekend binnen het Antwerpse en nu ook internationaal. De bedrijfscultuur is vlak en open...
-
Program Director
il y a 3 semaines
Antwerp, Belgique Antwerp Management School Temps pleinCompany detailsAt Antwerp Management School (AMS), an internationally renowned business school with its roots and main branch in the bustling heart of Antwerp, both young and experienced professionals are supported and guided in their quest for healthy growth and sustainable professionalisation in order to create impact as an individual, business team,...
-
Sales Director
il y a 3 semaines
Antwerp, Belgique WhatJobs Temps pleinOur client is a leading software vendor with an excellent reputation for providing solutions and working with leading clients. They are looking for an experienced individual who will lead a key account and help to shape the relationship and engagement over the medium and long term. This individual will be tasked with working with the C-Suite and become the...
-
Sales Director
il y a 3 semaines
Antwerp, Belgique Atherton Stone Temps pleinOur client is a leading software vendor with an excellent reputation for providing solutions and working with leading clients.They are looking for an experienced individual who will lead a key account and help to shape the relationship and engagement over the medium and long term. This individual will be tasked with working with the C-Suite and become the...
-
Director, Strategy
il y a 3 semaines
Antwerp, Belgique Board of Innovation Temps pleinAbout UsBy living and working with intelligent technologies, businesses and the humans that drive them will operate at a level far beyond our previous potential. We call this the autonomous age. This will create a paradigm shift for humanity, positively impacting everything from drug discovery to disease management. From the crops we grow, the products we...
-
Sales Associate
il y a 2 semaines
Antwerp, Belgique DRIES VAN NOTEN Temps pleinGuided by an inner creative compass that is unaffected by fleeting trends, Dries Van Noten is renowned for his signature eclecticism—a fearless juxtaposition of print, weave, color, and cut that yields captivating results transcending time and fashion cycles. In 2022, the brand expanded into beauty and fragrance with the launch of gender-fluid fragrances...
