Regulatory Affairs Specialist - United States of America

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 United States of America to join our growing Regulatory Affairs team at Clinglobal. This position offers the opportunity to work remotely with the visits at the office situated in Waverley, New York as required. 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 US 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 may require regular travel.

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Data Protection and Privacy

The Company complies with local and international data protection and privacy legislation. This includes transparency in the processing of personal information processed about job applicants during the recruitment process. By applying for this position, applicants agree to the processing of their personal data in accordance with our recruitment procedure and Privacy Notice available from our website.

As part of the hiring process, candidates need to willingly take part in personality and behaviour assessments to determine a good fit for the job role. These assessments assist with evaluation of candidates in a fair and thorough manner. All information gathered are kept private and only used to assess suitability for the job role.

The Company may perform criminal and/or other relevant checks (as is relevant to the position) on all applicants applying for this position.