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Regulatory Affairs Specialist Eu

vor 3 Wochen

Frankfurt am Main, Deutschland Clinglobal Group Vollzeit

**Regulatory Affairs Specialist - European Union**

Clinglobal is an Animal Health Contract Research Organisation and supports our global operations in various countries. We are currently looking for a** Regulatory Affairs Specialist** based in the EU to join our growing Regulatory Affairs team at Clinglobal. This position offers the opportunity to work remotely with visits to Clinglobal and partner companies' offices as required. The position is well suited for an individual who pride themselves on consistent and accurate work delivery and prefers an organized and structured environment. This position reports to our Director: Regulatory Affairs based in the US.

**Primary Job Purpose**

Responsible for coordination, compilation, and management of documentation for submission for development project registrations to regulatory authorities for external clients. Also responsible for supporting internal regulatory processes, and keeping the company updated on regulation pertaining to the business.

**Job Specific Duties and Responsibilities**
- Compiles and maintains regulatory documentation in the appropriate database or system
- Coordinates efforts associated with the preparation of regulatory documents or submissions with internal and external partners
- Coordinates and prepares regulatory submissions for EU projects
- Supports and helps maintain a regulatory projects roadmap that forecasts critical regulatory initiatives and mitigates regulatory risks for customers and Clinglobal projects
- May support regulatory maintenance activities as required per external partner project needs, such as compiling and preparing adverse event report submissions, and promotional material submissions to the appropriate regulatory authorities if required
- Remains knowledgeable about current regulations and guidance and supports the maintenance of internal regulatory standard operating procedures
- Supports other regulatory related activities as required

**Qualification, Training and Experience Requirements**
- BS in Science or Healthcare preferred or equivalent relevant experience.
- 2- 5 years of related regulatory affairs experience in the animal health industry.
- Effective communication skills.
- Excellent knowledge and understanding of current industry regulations and applicable local legislation.
- Must be willing and able to travel locally and internationally.

This position is a **Remote** position that requires regular travel.

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