Regulatory Metadata Coordinator
Are you experienced in pharma regulatory? You will be part of a dinamic, multicultural team that helps to develop and apply strategies, designed to ensure regulatory submission and compliance.
Tasks:
- Promote/Communicate on Regulatory Data process/timeline with RA community, and contribute to the planning of the regulatory submission.
- Ensure that accurate and up-to-date regulatory information on products, under development, approved and marketed, worldwide is available to all stake-holders.
- Assist the Publishing & Regulatory Data Entry Manager in providing Global Submission view and strategy Worldwide, in line with Regulatory Strategic Planning.
- Ensure that metadata submitted to the Health Authorities (HA) and coming from HA are accurate and that Ipsen Regulatory tracking system is aligned.
- Assess Submission strategy impact on Regulatory Tracking System and ensure that Regulatory Tracking System is appropriately maintained.
- Maintain a continuous flow of information to and from Publishing, GRA, LRAs and Regulatory Operations teams in particular with regards to tracking.
- Oversee Service providers for the Centralized Data Entry and HA document upload activities.
Requirements:
- Fluent English
- Strong analytical and problem-solving skills
- Good judgment and decision-making skills
- Excellent negotiating and influencing skills
- Planning, coordination and Project Management skills
- Experience in continuous improvement projects and quality management
Advantages:
- Bachelor Degree in Life sciences/Pharmacy
- Up to 2 to 4 years of experience in Regulatory affairs and submission, with Corporate experience
We offer:
- Career in a global environment while contributing to health and safety of the patients
- Opportunity for you to support one of the world’s most prestigious pharma companies
- Working in an international, young and dynamic team
- Competitive salary and benefit package
- Internal trainings and career path
Sector (s):
- Healthcare, Pharmaceutical Industry
- Healthcare Specialist
- Pharmacist
Experience required:
- 1-5 years’ professional experience
Required Qualification:
Required language level:
- English (higher advanced/fit for negotiation)
Employment type:
If you are interested, send your English CV to info@foxhr.hu
