Job Reference: TJBMAN1507
Job Duration: 12 Months
Start date: a.s.a.p
Description:
Main Responsibilities:
- As a member of the Regulatory Strategy & Intelligence team you will contribute to the action plan to implement ISO IDMP standards within the company
- Contribute to the company System Delivery and Data Migration Workstreams to ensure activities are on-track and meet IDMP requirements in the new RIM system
- Contribute to the review of draft ISO IDMP requirements/guidance documents with internal alignment
- Support process changes at global and local levels to ensure compliance with HA requirements (planning,compilation, publishing and submissions to HAs according to the right format)
- Work with external Business Consultancy according to company needs
Candidate Profile:
- Education: Life Science Degree (e.g. Chemistry, Pharmacy, Biology), or MBA (ProjectManagement)
- Languages: Fluency in English as a business language. Additional language is an asset
- Professional experience:
* 3-5 years of experience in Regulatory submissions in Europe (post-marketing experience in CMC, Labeling variations, xEVMPD)* 3-5 years of experience in Project management and Submission management
* Experience in using RIM systems and publishing related software/tools
* Good knowledge of the drug development process and submission guidelines
* Good knowledge of publishingprocesses.
For further details about this role, or to discuss other opportunities within Regulatory Affairs, please contactTim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk
Industry: Pharmaceuticals
Salary: €50.00 - €70.00 per hour
Salary Benefits:
Vacancy Type: Contract
Job Skills: regulatory affairs, regulatory, basel, switzerland, cmc, publishing, post approval
Contact Name: Tim Barratt
Website: -
Direct Application URL: -