Regulatory Affairs, Senior Associate

Description Overview

In this role you will be responsible for the hands on regulatory activities required to maintain existing commercial products, and support in making correct and timely new product applications of Perrigo products on the Turkish market. You will support to ensure compliance with the existing legislation for Medicines, Medical Devices, Biocides and Cosmetics. Another key aspect of the role will be supporting in the achievement of the overall Regulatory, Quality & Safety objectives and timely realization of operational activities.  In this position you collaborate closely with the Corporate Regulatory and Turkish Commercial colleagues to strive to help the customer the best.

Scope of the Role

• Support in the management of change by preparing applications and technical files in support of existing commercial product regulatory maintenance;
• Support in the regulatory activities on new product development (NPD), including artwork approvals, label claims and associated supporting documentation;
• Develop and approve label specifications (master text and local artwork text) in compliance with SOPs, as well as promotional materials from a regulatory perspective;
• Maintain regulatory files and data systems in compliance with SOPs;
• Represent regulatory affairs in project meetings with both Perrigo staff and external contacts;
• Follow up on changes in (inter)national regulations and legislations, and support in the interpretation, communication and implementation;
• Liaise with Corporate Regulatory, responding to regulatory queries and providing and review of registration documents as necessary for the Turkish and/or European territory;
• Support in the communication with local regulatory authorities regarding license applications and notice of change.

Experience Required

• University Degree in a Scientific Subject;
• Minimum of 2 years work experience within Regulatory Affairs required, within at least one of the following categories Medical Devices, Biocides, Cosmetics and Medicines;
• Excellent communicator in Turkish and English;
• Proficient computer skills esp. Microsoft (word, excel, powerpoint); experience with Veeva, TVT, Trackwise is an asset;
• Eye for detail, punctual, well organized;
• Being flexible and adaptable to change;
• Ability to support several concurrent projects/products simultaneously;