Are you the Regulatory Strategy Consultant we’re looking for?

 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 This email address is being protected from spambots. You need JavaScript enabled to view it. your CV and motivation.

 

Are you the Regulatory Manager we’re looking for?

 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 labeling 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 This email address is being protected from spambots. You need JavaScript enabled to view it. your CV and motivation.

Click here for more information

Are you the Regulatory Labelling Manager we’re looking for?

 You:

  • Have an MSc in Life Sciences or equivalent by experience
  • Have affinity with Regulatory landscape and procedures within the country/region
  • Enjoy being responsible for labeling updates, translations and submissions
  • Use your (verbal and writing) communication skills to inform, align and motivate team members
  • Are a good organizer and planner with attention for detail
  • Are flexible and able to handle deadlines and high workload

We:

  • will coach you and provide training, if needed
  • invite you to apply by This email address is being protected from spambots. You need JavaScript enabled to view it. your CV and motivation.

 Click here for more information.

Are you the CMC Regulatory Manager we’re looking for?

We offer a job as a CMC Regulatory Affairs manager, in which 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) 610489150.

We look forward to your application. You can apply by This email address is being protected from spambots. You need JavaScript enabled to view it.  your CV and motivation.

 

Are you the Regulatory Consultant - Pharmacovigilance we’re looking for?

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 This email address is being protected from spambots. You need JavaScript enabled to view it. your CV and motivation.

Check out the detailed description!

Are you the Medical Devices Professional we're looking for?

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
  • prepare and maintain ISO 13485 quality management systems

We:

  • will coach you and provide training, if needed
  • invite you to apply by This email address is being protected from spambots. You need JavaScript enabled to view it. your CV and motivation.

Check out the detailed description!

Zwiers Regulatory Consultancy | Pivot Park | Henry Chesbrough building | Kloosterstraat 9 | 5349 AB Oss | The Netherlands
Zwiers Regulatory Consultancy | Matrix V |Science park 406 | 1098 XH Amsterdam | The Netherlands

Tel +31 (0)6 10489150 | info@az-regulatory.com