Senior Regulatory Affairs Specialist

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 with in 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
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
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!
CARBOGEN AMCIS is a leading service provider in the area of product and process development, including the commercial production of active ingredients for the pharmaceutical and biopharmaceutical industries. We have 4 facilities across Switzerland (Aarau, Hunzenschwil, Bubendorf, and Vionnaz), as well as locations in St-Beauzire (FR), Manchester (UK), Shanghai (CN) and Veenendaal (NL). Our success is based on the high professional and personal competence of our employees.

Learn more about careers opportunities at CARBOGEN AMCIS at:

CARBOGEN AMCIS AG
Nieuweweg 2a, 3901 BE Veenendaal
The Netherlands
Tel.

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