Are you interested in working in the ever-changing regulatory environment?

We're continuously looking for skilled Regulatory Team Members

The regulatory world is dynamic and challenging and requires a specific set of competencies. A solid scientific background combined with regulatory skills and the right attitude is necessary
Local safety officer
You:
  • have a BSc degree or higher (preferably in life or health sciences, pharmacy, nursing, medicine, or biology)
  • have 2 or more years of experience in Pharmacovigilance (PV) / drug safety
  • are eager to take on a job in which you will be local safety representative (and back-up LQPPV) for products in the Benelux
  • are looking forward to take on any relevant additional task (e.g. case management, HA interactions, audits, reconciliation, surveillance)
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!

Experienced Regulatory Consultant Medical Devices
You:
  • have an MSc/PhD in Life Sciences, Medical Biology, Chemistry, Pharmacy
  • have substantial experience in Development & Regulatory Affairs in the Medical Device industry
  • like to be in a dynamic strategic position in medical device development and life cycle
  • will write and update technical documentation (eg. BE, CE, RM)
  • will interact with notified bodies and authorities
  • will write regulatory strategy plans
  • perform 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!

Business Development Manager Benelux
You:
  • look forward to being responsible for business development for our company (NL, Benelux) authorities
  • have experience with setting up and executing business development plans, portfolios, deal pipelines, prospect meetings, bid defences in line with company strategy and sales targets
  • have a MSc in business development and a minimum of 5 years of experience in it in the life science industry
  • are a good communicator (in writing and verbally in Dutch and English) and team player
  • are able to take on challenging tasks in a creative, proactive and convincing way while handling stringent timelines
We:
  • offer an international 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.

Click here for more information

Local Regulatory Affairs Manager
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.

Click here for more information

Experienced Regulatory Strategy Consultant
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

Regulatory Manager CMC
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.

Medical Writer
 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.

Pharmacovigilance Consultant
You:
  • have a PhD in Pharmacy, Medical Biology, Life Sciences
  • have 3 years of experience in PV
  • will ensure compliance with safety-related marketing authorisation commitments and obligations
  • 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!

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Zwiers Regulatory Consultancy is a ProductLifeGroup Company

ProductLife Group’s mission is to improve human health by delivering regulatory & compliance services for the safe and effective use of medical solutions. PLG supports clients through the entire product life cycle, combining local expertise with global reach spanning more than 150 countries.

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