Regulatory Metadata Coordinator

Cég: SwiconGroup

Your daily tasks on the job

We're looking for a Regulatory Metadata Coordinator to assist the Publishing & Regulatory Data Entry Manager in providing Global Submission view and strategy Worldwide, in line with Regulatory Strategic Planning.

- To ensure that metadata submitted to the Health Authorities (HA) and coming from HA are accurate and that Ipsen Regulatory tracking system is aligned.
- To assess Submission strategy impact on Regulatory Tracking System and ensure that
Regulatory Tracking System is appropriately maintained.
- To oversight Service provider(s) for the Centralized Data Entry and HA document upload
activities.
- Promotes/Communicates on Regulatory Data process/timeline with RA community, and contributes to the planning of the regulatory submission.
- Ensures that accurate and up-to-date regulatory information on products, under development, approved and marketed, worldwide is available to all stake-holders.
- Maintains a continuous flow of information to and from Publishing, GRA, LRAs and Regulatory Operations teams in particular with regards to tracking.


Education

Bachelor Degree


Language skills

English


We are looking for...

- Strong written and oral communication skills
- Must exhibit excellent interpersonal, collaborative and team spirit mindset, good communication and follow-up skills
- Willingness to work in a fast-paced environment with stringent timelines
- Experience in continuous improvement projects and quality management


Work environment

Friendly and welcoming work environment with an international working atmosphere where you can practice and learn new language skills with a diverse mix of colleagues and clients.


Professional experience

- Up to 2 to 4 years of experience in Regulatory affairs and submission, with Corporate experience
- Excellent planning, coordination and Project Management skills
-Good negotiating and influencing skills
- Good judgment and decision-making skills
- Strong analytical and problem-solving capability with attention to detail


About company

SwiconGroupis one of the leading members of the IT arena for almost a decade. Our wide range of services and highly trained professionals give us the opportunity to shape our solutions to fully meet the ideas and wishes of our clients. We are proud to have leading banks, insurance and telecommunication companies, as well as large FMCG corporations and SSCs amongst our highly prestigious partners.


Other benefits

Competitive salary package
Excellent work environment
Continuous professional development
Supporting working environment
Home Office


Gross salary

650000 - 700000 Ft


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