Publishing Coordinator Regulatory Operations - Belgium
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Role and main tasks:
- manage and execute the timely publishing and distribution process for regulatory submissions (such as the initial submission file to obtain the Marketing Authorization Approval for Europe or international markets, dossiers for the WHO, complex variations, renewal files) to regulatory agencies.
- maintain and continuously develop a high level of technical expertise of the submission tools and EU and international legislation in this context.
- contribute to establish a performance dialog in terms of capacity management in capacity cross-business meeting for publishing activities.
- develop and maintain Regulatory Affairs department operational databases to provide up-to-date reliable information systems within the department.
- ensure archiving of regulatory dossiers (electronic and paper forms) for Regulatory Affairs Department.
- flag operational issues and propose solution in a timely manners.
- ensure adherence to legal constraints, local and international standards, Regulatory requirements and all the client's policies and procedures as applicable.
- The Publishing Coordinator is evolving in a complex and changing environment.
- B.Sc. technical degree, or equivalent by expertise; Good standard of education level including English Language and basic IT tools
- Ideally 3 years RA experience in the pharmaceutical industry
- Knowledge of the pharma industry and regulatory (operations) specifically is an advantage
- Aptitude for working with electronic databases, publishing tools as well as the potential for managing complex information within regulated environments.
- Project management to compile and dispatch on time regulatory documentation.
- Experience in communicating to various stakeholders
- Experience in higly regulated environment
- Good communication, presentation and influencing skills
- Great motivation and team spirit
- Structured and strong organizational skills
- Rigor, quality minded and eye for detail
- Skills in information, document and database management
- Good prioritization skills in function of business impact and criticality
- Skills in information, document and database management and publishing tools.
- Stress-resistant – Flexibility
- Customer oriented
- Publishing tools (Liquent’s Insight, CSC eCTDXPress and Publisher or equivalent) is a plus
- MS Office
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
- Our company 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.
- 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.