Regulatory Affairs Manager oversees the regulation process for products requiring governmental approval, including filing necessary applications and handling all government interactions. Coordinates inspection of the organization and contract facilities, and develops procedures to ensure regulatory compliance. Being a Regulatory Affairs Manager requires a bachelor’s degree in area of specialty. Typically reports to top management. 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. Extensive knowledge of department processes. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 to 3 years supervisory experience may be required.
Regulatory Affairs Manager Job Description Template
Our company is looking for a Regulatory Affairs Manager to join our team.
- Coordinate accreditation assessment visits of the MQA;
- Ensure the MQA accreditation of all academic programmes;
- Provide advice and support in the areas of educational quality assurances and its processes;
- Provide regular reports and updates to the senior management team as and when requested;
- Collaborate with Deans and Heads of Department to ensure compliance with regulatory requirements, related policies and business rules;
- Maintain a database of all MOUs with partner universities Staff Management;
- Maintain the programme standards and approved entry requirements by MQA and Nilai University Senate for both foreign and local students;
- Monitor MOE, MQA and KDN regulations and policies on approval, reapproval and accreditation and ensure compliance;
- Effectively manage the staff and resources of the Department of Regulatory Affairs, Quality Assurance & Audit;
- Maintain a database of all information pertaining to regulatory and rating requirements; MOE approval letters and MQA certificates for programmes;
- Manage the institution’s benchmarking activities;
- Coordinate and manage the institutional and academic performance audits of external bodies;
- Apply for changes when necessary of curricula and entry qualifications;
- Liaise with MOE, MQA, KDN and other government agencies to apply for and maintain all relevant licenses and permits;
- Manage the development, implementation and enhancement of academic and non-academic standard, policy and procedure.
- Strong interpersonal skills to deal with sensitive and occasionally contentious issues. – Problem solving – Team collaboration working;
- Highly organized;
- Knowledge of regulatory requirements, Health Authorities regulations & guidelines;
- Demonstrated ability to manage multiple assignments;
- Ability to work cross –functional to resolve complex issues;
- Demonstrated high-level management and planning skills;
- Desire to work as part of an effective, cohesive group;
- Proficient computer literacy skills in Microsoft Office applications;
- Confident communication skills, both verbal and written.