Regulatory Operations Specialist
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 Noord-Holland Netherlands.
Our client is a global biopharmaceutical company, focussing on theraputic drugs for autoimmune and rare disease speciality areas.
ROLE DESCRIPTION
As a regulatory operations specialist you will be managing and coordinating the Regulatory Operation activities of the site.
RESPONSIBILITIES
• Establish or update functional databases for: correspondence archiving, company regulatory dossiers and product information.
• Support the maintenance of the regulatory information database and other regulatory information management lists.
• Coordinate the preparation of the local and global dedicated SOPs and training of RA colleagues on use of IT tools such as publishing tool, eDMS (in scope of submission documents), Regulatory Database and other information management lists
• Collaborates to the preparation of global SOPs / Work Instructions
• Ensure the support for publishing of regulatory submissions marketing authorisation applications, variations, annual reports etc. in a timely and efficient manner
• Ensure support for the archiving of regulatory submission.
• Identifying regulatory opportunities or issues and problems related to designated IT tools and recommending solutions.
• Maintaining update on CTD and eCTD regulations relevant to Template management and submissions templates and style guide are in place and that relevant requirements can be fulfilled.
• Manage activities of in-house and external consultants, including monitoring progress and checking assignments for quality, fidelity and accuracy.
REQUIREMENTS
Qualifications
• Bachelors or Masters degree in a scientific discipline (also a background in IT is preferred).
• Excellent communication and writing skills in English is a must
• Experience with Pharmaceutical Regulatory Operations and data programs
• Being familiar with electronic publishing systems
• Being up-to-date on international and national regulatory legislation and procedures
• Good negotiating and communication skills
• Persuasive personality
• Ability to maintain long term working relationships with customers
• Good adaptability skill
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Linn Andenes.
