Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
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
Qualification, Training and Experience Requirements
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.
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