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Senior Regulatory Affairs Specialist

CARBOGEN AMCIS
Veenendaal

Snel solliciteren

Vacaturegegevens

Vaste baan | Fulltime
€ 5.750 - € 6.500 per maand
11 uur geleden

Secundaire arbeidsvoorwaarden

Extra vakantiedagen
Pensioen
Budget voor professionele ontwikkeling
Bedrijfslaptop

Kwalificaties

Engels
Master
Analytisch vermogen
Farmacie
Scheikunde
Communicatieve vaardigheden

Volledige vacaturetekst

Are you an experienced regulatory professional who wants to make an impact for our international clients in the pharmaceutical, cosmetics, and food industries? Then we would love to talk to you!
Due to the expansion of our team in Veenendaal, we are looking for a Senior Regulatory Affairs Specialist responsible for the coordination and compliance of registration dossiers. You report directly to the corporate Head of Regulatory Affairs & CMC in Switzerland and coordinate CMC regulatory activities in Veenendaal.

What you will be doing

You prepare and maintain registration dossiers (CEP, DMF, ASMF) for our Active Pharmaceutical Substances and new substances/markets.
You coordinate the submission of registration dossiers within the RAC department to the relevant Health Authorities and monitor compliance.
You are performing a regulatory review of CMC source documents and advise on any additional development activities required.
You assess the regulatory impact of changes in production and validation processes, change control, and deviations.
You maintain contact with Health Authorities and clients and respond to their questions.
You identify new laws and regulations and translate these into concrete regulatory actions.
You manage the REACH registration dossiers and support applications for Health certificates (NVWA)
You support internal improvement (local and global) and client-focused regulatory projects.

What you bring

You hold a Master's degree in Chemistry, Pharmacy, or a comparable field.
You have at least 7 years of experience in the pharmaceutical industry/GMP environment, including several years within Regulatory Affairs combined with a CMC background.
You have demonstrable experience in preparing regulatory dossiers (with a focus on the EU and US markets).
You have solid knowledge of cGMP and ICH guidelines and regulatory requirements for the pharmaceutical, cosmetics, and (animal) feed/food industries.
Experience within a CDMO environment, or experience working directly with clients on regulatory projects, is an advantage.
Knowledge of the submission process using eCTD submission software (we work with Docubridge) is an advantage.
You have excellent communication skills, both in Dutch and English.
You are proactive, a team-player, solution-oriented, analytical, and client-focused.

What we offer you

Indicative salary € 5.750 - € 6.500 (based on full-time employment), depending on your experience and skills
Permanent contract from day one
13th month salary
Personal annual choice budget of 6.6% of your gross annual salary, plus an additional annual gross contribution of € 1.100 (exchangeable for extra leave days and/or salary)
Holiday allowance of 8% over your annual salary and 13th month salary
Commuting allowance of € 0.25 per kilometer or full reimbursement of public transport costs
26 vacation days
Laptop and smartphone
A solid pension scheme with Zwitserleven
Continuous travel insurance (including private use)
Possibility of hybrid working
Various training and development opportunities
A pleasant working atmosphere with plenty of staff and team activities where you get to know your colleagues better!

Salaris: €5.750,00 - €6.500,00 per maand

Werklocatie: Hybride werken in Veenendaal

Snel solliciteren

Verfijn je zoekopdracht

solution specialist vacatures in arnhem, ge

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Ik wil de nieuwste vacature-alerts ontvangen voor de functie van solution specialist in arnhem, ge

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