Clinical and Regulatory Analyst - II

Education: Bachelor of Science degree (minimum) in science, engineering, or other relevant field (advanced degree preferred).

Experience: At least 4 years of previous Regulatory CMC experience. Working knowledge of CMC related regulations and guidelines (including but not limited to FDA-CVM, EMA, and VICH), authority expectations, as well as current industry standards. Proficient in English, high level of professionalism, experience reviewing scientific information, demonstrated oral and written communication skills. Demonstrated understanding of related fields (manufacturing, packaging, quality control, and quality assurance).Leadership skills (problem solver, ability to deal with multiple priorities. Multitasker. Strong interpersonal skills to collaborate with internal partners and liaise with regulatory authorities (CVM/FDA) as needed, sound judgement and attentive to details).

Responsibilities: The Senior Specialist is responsible for developing CMC regulatory submission strategies and timelines for assigned pharmaceutical projects/products in accordance with global regulations and guidance. The Senior Specialist is also responsible for the preparation and review of information required for development of regulatory CMC dossiers for new and existing commercial products. Major activities and responsibilities: Work independently and effectively with relevant functions to manage and prepare regulatory CMC dossiers, renewals/annual reports, variations/supplements, and responses to authority questions as required in each country in order to gain new and maintain existing product registrations. Provide regulatory assessment for post approval change proposals, filing strategies and timelines, identify risks and propose mitigation strategies. Ensures important submissions/tasks are completed on a timely basis. Actively participate on new product development teams as well as other project teams and initiatives and deliver on all assigned regulatory milestones. Maintain regulatory information in accordance with processes and procedures to support regulatory compliance. Continuously build and share knowledge of CMC related regulations and guidelines (including but not limited to FDA-CVM, EMA, and VICH), authority expectations, as well as current industry standards. Identify and communicate potential regulatory issues to management, as needed. Performs other tasks as requested by management.