You:

• look forward to being responsible for timely submission and correspondence of regulatory content to national (NL, Benelux) authorities
• have experience with local/regional regulations, preparation of local submission documents, translations of product information, eCTDs and variations and promotional materials
• have a BSc/MSc in Life Sciences and a minimum of 2 years of relevant regulatory experience
• are a good communicator (in writing and verbally) and team player
• are able to handle stringent deadlines and manage multiple projects simultaneously

We:

• will coach you and provide training, if needed
• offer a working environment in which a professional approach goes hand-in hand with a personal touch
• invite you to apply by sending us your CV and motivation.

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You:

• have an MSc/PhD in Pharmacy, Medical Biology, Chemistry, Life Sciences
• like to be in a dynamic strategic position in drug development and life cycle
• have three to five years of experience in Regulatory
• will be involved in innovative drug development
• will prepare regulatory dossiers for clinical trial applications, orphan drug designations, paediatric investigational plans, marketing authorisation procedures and health authority meetings
• be involved in defining global regulatory strategy
• want to live up to the Zwiers “professional approach with a personal touch” spirit

We:

• will coach you and provide training, if needed
• invite you to apply by sending us your CV and motivation.

Click here to check out a more detailed description

You:

• have an MSc/PhD in Pharmacy, Chemistry, Medical Biology, Life Sciences
• will prepare and update technical documentation (eg. BSER, CER, RMP)
• will coordinate and manage interactions with notified bodies
• implement and maintain ISO 13485 quality management systems
• perform IVD and medical device directive vs. regulation gap analysis

We:

• will coach you and provide training, if needed
• invite you to apply by sending us your CV and motivation.

Check out the detailed description!

You will:

• optimally use your MSc/PhD (in Pharmacy, Chemistry or Life Sciences) and interest in drug manufacturing and the control strategies for it
• work in an international environment of pharmaceutical industry, with focus on Chemistry Manufacturing and Control
• review reports on pharmaceutical product and process development
• “translate” scientific lab results into regulatory supportive dossier documents
• prepare and coordinate regulatory submissions and marketing authorisation procedures
• stay up to date with literature and guidelines
• be coached by Zwiers

You have:

• an MSc/PhD in Pharmacy, Chemistry, Life Sciences
• (scientific and technical) writing and editing skills (English)
• knowledge of/affinity with analytical procedures, specifications, validation methods, stability testing, process controls etc.
• the eagerness to learn, develop and excel
• the ability to handle stringent deadlines
• the ability to communicate in a convincing way

Offer

Salary will depend on education, knowledge and experience

Contact

For further information you can contact Alex Zwiers, CEO, at tel. +31 (0)6  344 848 51.

We look forward to your application. You can apply by sending us your CV and motivation.

 You have:

• an MSc/PhD in Pharmacy, Biomedical Sciences, Life Sciences
• scientific and technical writing and editing skills (English)
• an eye for detail
• the ability to handle stringent deadlines
• the eagerness to learn, develop and excel
• the ability to communicate in a convincing way
• at least 3 years of experience as a medical writer or comparable writing position

We:

• will coach you and provide training, if needed
• invite you to apply by sending us your CV and motivation.

Click here for more information.

You:

• have a PhD in Pharmacy, Medical Biology, Life Sciences
• have 5 years of experience in PV
• will ensure compliance with safety-related marketing authorisation commitments and obligations
• will take on the role of QPPV will write and review pharmacovigilance-related documents
• will review safety findings from literature and manage pharmacovigilance databases

We:

• stimulate you to give us a call before applying
• offer a working environment in which a professional approach goes hand-in hand with a personal touch
• invite you to apply by sending us your CV and motivation.

Check out the detailed description!