benefit of the company to ensure approval and Product supply continuity. • Assess and communicate potential regulatory risks and propose mitigation strategies. • Deliver all regulatory milestones for assigned products across the product lifecycle • Identify, communicate and escalate potential regulatory issues to GRACS CMC management, as needed" Required Qualifications "• Strong experience in CMC requirements for small molecule/biologic products. • Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data. • Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills. • Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving. • Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders. • Demonstrated flexibility in responding to changing priorities or dealing with unexpected events. • Demonstrated effective leadership, communication, interpersonal and negotiating skills. • Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines. " "Desired CMC 3 - At least seven (7) years of relevant experience, including research; manufacturing, testing, or licensure of pharmaceutical Device/instruments; or related fields