Freelance Regulatory Submission Planner

Typical duties will include:
Identifying and gathering local documents from country Regulatory Affairs team (mainly for MRP/DCP and NP products). Developing the submission plan, ensure all components are obtained. Generating work order for dossier publishing teams. Reviewing submission before release

Responsibilities:

* planning, coordinating and reviewing regulatory submissions (mainly variation applications) to European countries (EU, non EU countries, Switzerland)
* obtaining supportive documentation for the regulatory submissions and for ensuring the assembly is performed by the publishing teams
* responsible for the release to the Country Regulatory Affairs
* tracking the submission milestones of the assigned work
* maintaining the regulatory submission planning and registration tracking databases to fulfil daily function and Records Retention tracking and management

Essential Skills & Capabilities:

* A minimum of a Bachelor's Degree
* 3-5 years' experience in the pharmaceutical regulatory affairs area
* Excellent written and oral communication/interpersonal skills required
* Able 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 level (oral and written)

We try our best to respond to every application and you can be sure every single one will be reviewed. Due to the potential high volume of responses should you not hear back within 10 days from your application assume you have not been successful on this occasion.

For further details or a confidential conversation please contact me directly
Diana Fryzowicz
Recruitment Consultant - SEC Pharma
Tel: (see below)