Login
Not registered? Sign up now

Regulatory & Quality Coordinator (The Netherlands)

Bedrijfsprofiel

The position

This person will be responsible in the compiling, submission and approval activities for New Drug Application (NDA) and Life Cycle Management (LCM) licences under supervision of RA Coordinator CL-PE. Monitor local regulatory environment and ensure compliance. Develop local labelling and ensuring the regulatory compliance in promotional material.
  • Monitor local regulatory environment and ensure regulatory compliance
  • Maintain records on legislation, regulations and guidelines: check Health Authorities’ (HA) website, official gazette, offline systems, archive, ISOtrain.
  • Conduct research on submission requirements and options.
  • Responsible in monitoring and reporting project timelines.
  • Provide information on local regulatory requirements to other departments and/or Business Areas (BAs).
  • Draft routine correspondence to regulatory agencies.
  • Manage regulatory archiving according to local legislation and Standard Operational Procedures (SOP).
  • Submit and monitor local permits for importations and LHA product release process for biological products.
  • Establish and maintain open communication and cooperation with other departments (Marketing, Legal, Logistics, Sales.).
  • Active participation in meetings called by ALAFARPE as Technical Director of Novo Nordisk in Peru
  • Responsible for the compiling, submission and approval of NDA and LCM licences
  • Review the list of documents required for tenders or any other submission (e.g. NDA, variation) and provide on time product information as required.
  • Manage the compilation and preparation of regulatory documents, information, to support approvals for new product registration, renewals and variations. Ensure that all data and information submitted to HAs as part of a regulatory submission is documented.
  • Monitor applications under the different stages during HA evaluation and answer questions from the HA's.
  • Support to fulfil any post-approval commitments required by HAs.
  • Update and maintain paper/electronic document archival systems.
  • Support in developing labelling materials and review/approve promotional materials
  • Support in developing, reviewing and updating labelling material according to local legislation and SOP.
  • Review the promotional materials to ensure overall legal compliance with HA’s requirements.
  • Control the quality of local language’s translation.
  • Quality Assurance and Pharmacovigilance responsibilities
  • Oversees the compliance in local and corporate requirements related to regulatory, quality, pharmacovigilance and good storage and distribution practices for all Novo Nordisk products to be commercialized in Peru to assure the quality, stability and efficacy of the products.
  • Maintain QA system to comply with Global Safety SOPs and the local law.
  • Implementation of new Quality processes and improvement of current ones,
  • Responsible for Pharmacovigilance activities in Peru, including the submission of adverse reactions reports to DIGEMID and the submission of PSUR/RMP on time according Local Health Authority requirements.
  • Ensure that the QMS in affiliate is in compliance to NN and external requirements



Qualifications
  • We are looking for an experienced professional, with at least 3 years of experience at Pharmaceutical Industry, in Regulatory Affairs & Quality Assurance areas.
  • Graduated in Pharmacy
  • The candidate must have updated knowledge of local regulations for the correct importation, release, registration and maintenance of licenses for pharmaceutical and biological products.
  • An upper intermediate level of English and Spanish is required.

Company

Anonymous

Contact person

Want to know more?

Our customers
Pride Company uses cookies to remember certain preferences and align jobs interests.