Project Regulatory Affairs
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science 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!
THE COMPANY
Our client is a professional Pharmaceutical organization, based in Netherlands.
The client is big pharmaceutical company (generic) and dedicated to a future where healthcare will be challenged by entrusted patients. They want to improve access to medicines and related health care services to the people who need them.
ROLE DESCRIPTION
As RA officer you will be responsible for the registration dossiers to support the RA Managers. You'll be performing specialized activities in the submission process for all countries within their cluster or even region.
RESPONSIBILITIES
As a Regulatory Affairs Officer you are responsible for:
1) Preparing, compiling and maintaining the registration dossiers to support the RA managers and contribute to the regulatory activities such as:
• Collection of information and preparation of dossiers and variation packages as required by global authorities
• Evaluation of the CMC data required to support dossiers and variations packages
• Creation of the product information texts and keeping them up to date
• Preparation of the responses to deficiency letters raised by regulatory authorities
• Compilation of the regulatory documents in eCTD or Nees
2) Submitting the registration dossiers, responses, renewals and variation packages in compliance with the strict deadlines
3) Coordinating the regulatory activities with customers, CMO’s and other third parties
4) Contributing to the agreed way of document management and keep the document management system up to date
5) Contributing to write and review the SOP’s applicable to the RA department
6) 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.
7) Participating in project teams with regard to implementation of regulatory requirements of the project.
8) Keeping updated knowledge of relevant new/draft legislation/regulation/guidance in the global regulatory affairs environment and apply them if required for pharmaceutical compliance.
REQUIREMENTS
- Academic degree in life science
- 2 or more years related in a pharmaceutical / biotechnological related industry in area of regulatory affairs;
- Excellent communication and writing skills in English
- Experience with eCTD is a plus
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Laura Hoekstra.
