Registration Specialist
Location: BelgiumSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Brussels Hoofdstedelijk Gewest Belgium.
- Preparing, compiling and maintaining the registration dossiers to support the RA managers and contribute to the regulatory activities such as:
o Collection of information and preparation of dossiers and variation packages as required by global authorities
o Evaluation of the CMC data required to support dossiers and variations packages
o Creation of the product information texts and keeping them up to date
o Preparation of the responses to deficiency letters raised by regulatory authorities
o Compilation of the regulatory documents in eCTD or Nees
- Submitting the registration dossiers, responses, renewals and variation packages in compliance with the strict deadlines
- Coordinating the regulatory activities with customers, CMO’s and other third parties
- Contributing to the agreed way of document management and keep the document management system up to date
- Contributing to write and review the SOP’s applicable to the RA department
- Keeping excellent proactive relationships as direct interface with the authorities and the regulatory affairs departments of DSP customers in order to maximize chances of approval.
- Participating in project teams with regard to implementation of regulatory requirements of the project.
- Experience within the pharmaceutical (generic) industry min 2 years
- Keeping updated knowledge of relevant new/draft legislation/regulation/guidance in the global regulatory affairs environment and apply them if required for pharmaceutical compliance.
- Working proficiency in English
The Company
They are a global leader in sustainable antibiotics, next-generation pharmaceuticals.Role Description
The company is looking for a Registration specialist whom can hit the floor running, start as soon as possible and work fulltime.Responsibilities
As Registration Specialist you will be responsible for:- Preparing, compiling and maintaining the registration dossiers to support the RA managers and contribute to the regulatory activities such as:
o Collection of information and preparation of dossiers and variation packages as required by global authorities
o Evaluation of the CMC data required to support dossiers and variations packages
o Creation of the product information texts and keeping them up to date
o Preparation of the responses to deficiency letters raised by regulatory authorities
o Compilation of the regulatory documents in eCTD or Nees
- Submitting the registration dossiers, responses, renewals and variation packages in compliance with the strict deadlines
- Coordinating the regulatory activities with customers, CMO’s and other third parties
- Contributing to the agreed way of document management and keep the document management system up to date
- Contributing to write and review the SOP’s applicable to the RA department
- Keeping excellent proactive relationships as direct interface with the authorities and the regulatory affairs departments of DSP customers in order to maximize chances of approval.
- Participating in project teams with regard to implementation of regulatory requirements of the project.
Requirements
- HBO or academic (WO) level- Experience within the pharmaceutical (generic) industry min 2 years
- Keeping updated knowledge of relevant new/draft legislation/regulation/guidance in the global regulatory affairs environment and apply them if required for pharmaceutical compliance.
- Working proficiency in English
Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
