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
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.

Regulatory Consultant Medical Devices
You:
  • have an MSc/PhD in Pharmacy, Chemistry, Medical Biology, Life Sciences
  • will prepare and update technical documentation (eg. STED, 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!

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
You:
  • have an MSc in Life Sciences or equivalent by experience
  • have affinity, and preferably experience, with regulatory procedures and processes
  • have good organizational, planning and communication skills
  • will ensure timely preparation, submission and follow-up of applications to competent authorities
  • will be responsible for decentralized and mutual recognition procedures
  • will maintain and compile product labelling and regulatory eCTD dossiers
  • are looking for an opportunity to benefit from both your accuracy as well as your scientific background
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

Regulatory PV Consultant
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!

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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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