Regulatory Operations Customer Service Support - Belgium
Keyrus Biopharma (company)
We are looking for a Regulatory Operations Customer Service Support for one of our clients based in Walloon Brabant.
The Regulatory Operations Customer Services Support is a Regulatory Operations Ambassador and first point of contact for the Regulatory Project Team.
He provides the daily core Regulatory Operations Services directly to the customer in support of Global Regulatory Affairs.
Role and main tasks:
Regulatory Operations Customer Services Agent is responsible for delivering the following key services to Global Regulatory Affairs team in support of achieving Global Regulatory Affairs business objectives:
- Responsible to support and consolidate the Regulatory Project Teams Planning and Tracking for Project/Products under responsibility
- Update the company’s Regulatory Information Management System with everyday information provided by Regulatory Project Teams for all submission activities
- Responsible for Manufacturing Change control Process entries (Request for Process Change) within Global Regulatory Affairs department for Technical Variation creation in Regulatory Information Management System
- Provide ad hoc refresher training to Global Regulatory Affairs team where users would benefit from learning more about how to effectively use the company’s tools and systems
- Responsible for the pre-publishing (creation of the structure within the company’s electronic Document Management System (eDMS) and the sequence within the Regulatory Information Management System
- Global Regulatory Affairs Responsible for making the link between Local Operating Companies and industrial department for sharing regulatory status & allowing QA release and supply business continuity. The Customer Services Agent represents Global Regulatory Affairs and is a core team member of product meetings
- Provide advice and support regarding the technical aspects of electronic submission build and delivery: i.e. eCTD configuration / lifecycle management and conversion to other submission formats to maximize reuse
- A1 Bachelor – Administration background, with a mininmum of 5 years of experience
Hard skills :
- General subjects demonstrating an aptitude for working with electronic databases and toolsets as well as the potential for managing complex information within regulated environments
- Qualifications / skills in information management, database management, customer services and marketing
Soft skills :
- Communication skills
- Good cultural awareness
- Logical/process orientated approach
- Good adaptability skills
- Ability to manage multi-tasks
- Team player
- Problem solving skills
- Sound Judgment
- Sense of Purpose
- Flexible thinking
- Continuously identifying ways to simplify and improve things
- Customer driven
- Enable and drive change
- Building relationships
What we offer
You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…). Each employee will be welcomed with a varied integration program. We invest considerable time and resources in training our staff (technical and non-technical courses). You will join a dynamic and international environment with enthusiastic and professional colleagues.
Who we are
Keyrus Biopharma is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
At Keyrus Biopharma we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
Keyrus Belgium Offices:
- Chée de Louvain 88 - Waterloo-Lasne
- Rue Emile Francqui, 1 - Mont-Saint-Guibert
- Nijverheidslaan 3, - Strombeeck Bever