Assistant Regulatory Affairs and Patient Safety 1

Job Description:

Mission

(COMPANY NAME) is a global pharmaceutical company with 1,765 employees with direct presence in more than 20 countries. (COMPANY NAME) has consolidated international coverage on a global scale thanks to owned subsidiaries and sales agreements with the most prestigious partners in key markets such as the USA, Japan and China.
We have helped to positively change hundreds-of-thousands of lives through our innovative products and solutions since 1943. We have 15% staff dedicated to R&D in cutting edge scientific research to find solutions for unmet patient needs. We care about skin health. Our medicines help to make a significant difference to patients' lives by treating a wide of range of skin diseases.
At (COMPANY NAME) regulatory and patient safety is of the utmost importance for the business and for the patients and prescribers.
The RA&PS assistant is of important support due to the huge quantitiy of bureacracy to manage.
This is an excellent opportunity if you are seeking for your next professional challenge in a role that covers a broad view of regulatory and patient safety activities that requires active interaction and participation in multidisciplinary teams and engaging with business partners across the globe.

Tasks and Responsibilities

* Organization of the department's agenda
* Administrative tasks of the Reinbek regulatory group. Recovery of tasks outsourced to Asphalion.
* Commercial Registry; Collecting new EMA and CMDh publications that may affect (COMPANY NAME) / Polichem products and informing appropriately to the RAMs.
* Organize visits of consultants, external companies and interviews, travel, congresses and courses.
* Regulatory Specific Documentation: prepare dossiers, documents, reports etc.
* Translation and apostilles. Processing of variations, visas.
* Distribution, updating, management and follow-up of the department's Registration Projects.
* Organize F2F or TC/Webex meetings with Subsidiaries.
* Follow-up, updating and filing of the Area's own personnel documents with HR.
* Management of new incorporations. Request PC's. Registration of company telephone and cell phone lines. Request programs

Education

* Bachelor´s degree, FP Administracion or College degree
* English fluency spoken and written

Values & Competencies

* Care; we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.
* Courage; we challenge the status quo, we take full ownership and we learn from our success & failures
* Innovation; we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets.
* Simplicity; we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple