Regulatory Submission Planner (Submission Development Lead)

Function:

The Regulatory Submission Planner will work within the Regulatory Operations-EMEA team. The person will be responsible for planning, co-ordination and delivery of electronic dossier for the regulatory filings required to maintain marketing authorization of the company medicinal products in Europe.

Responsibilities:

- Plan, co-ordinate and review regulatory submissions (mainly variation applications) to European countries (EU, non EU countries, Switzerland)
- Obtain supportive documentation for the regulatory submissions and ensure assembly is performed by publishing teams
- Release to the Country Regulatory Affairs
- Track submission milestones of the assigned work
- Maintain regulatory submission planning and registration tracking databases to fulfil daily function, Records Retention tracking and management

Primary tasks:

- Identify and gather local documents from country Regulatory Affairs team (mainly for MRP/DCP and NP products)
- Develop submission plan, ensure all components are obtained
- Generate work order for dossier publishing teams
- Review submission before release

Education:

- Bachelor's degree required experience in a regulatory environment
- Proven experience in the pharmaceutical regulatory affairs area
- Excellent written and oral communication/interpersonal skills required
- Ability to manage several submissions simultaneously and to multitask
- Enhanced skills for interacting and negotiating with others
- IT knowledge: working knowledge of the standard computer applications (MS Office applications, Adobe Acrobat, MS Project, Documentum)
- Ability to act upon assigned work responsible and to actively follow up on assignments.
- Able to collaborate effectively in a multi-cultural working environment
- Excellent English language skills