Qualifications. ">. Bachelor's degree in engineering, science, and/or health profession field. 10 years experience in regulatory affairs in the pharmaceutical industry. 3-5 years of experience in managerial role. Proven track record of increasing responsibilities with skills in leadership and management.
Responsibilities. ">. Assist in the preparation and compilation of domestic and international product submissions. Ensure agency establishment registrations and device/drug listings are completed on time. Support domestic and international field corrective actions and adverse event reporting. Develop and submit regulatory information requested during inspections.
Job Description. ">. As Director of Regulatory Affairs, you will play a key role in shaping our regulatory strategy and ensuring compliance with global regulations. You will work closely with cross-functional teams to develop and execute regulatory plans, manage submissions, and maintain relationships with health authorities. Your expertise will be crucial in navigating the complex regulatory landscape and driving business growth
Key Responsibilities. Provide leadership in the QC Unit to ensure compliance, drive improvements, and achieve schedule adherence in accordance with production timelines. Own and maintain the site's Environmental Monitoring (EM) Program. Evaluate microbial testing data to ensure timely completion of manufacturing operations and batch disposition activities. Escalate EM excursions and collaborate with cross-functional teams in their investigation a...
