Team Lead

Job Description

Role & responsibilities Hiring candidates with 6 to 12 years experience in CMC Regulatory Affairs in Pharmaceutical Industry across regulated and semi regulated regions with hands on experience into - Lead submissions for post approval changes, annual reports, and product renewals across regulated and semi regulated regions. Manage and contribute to CMC-related projects, initiatives, cross-functional special project teams and training activities, while adhering to the companys values and principles of integrity Initiate and maintain CMC product timelines at the direction of product lead and report status of activities and projects. Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions. Preparing submission content plans for CMC submissions including, CMC and amendments and renewals, postmarket supplements/variations, product renewals, Module 3 baselines, and annual report/notifications. Interface with the regulatory operations team. In depth understanding of Health Authority expectations for Injectables for regulated and semi regulated regions. Must possess organization skills, time management skills and attention to details. Must possess strong communication skills, critical thinking, interpersonal skills and interpretation skills. Should understand business presentation and communicate descriptions of problems and solutions. Preferred candidate profile M Pharm, MSc or B Pharm with experience in CMC Regulatory Affairs in Pharmaceutical Industry across regulated and semi regulated regions. Working experience into sterile/ parenteral products would be an added preference.