Senior Global Regulatory Affairs - CMC Scientist Consultant

Position Overview:This position will provide strategic, tactical and operational direction and support to expedite CMC development of our client’s clinical trial portfolio by developing successful regulatory strategies and submissions in support of clinical trials. In order to meet client expectations, it is necessary for our entire PSS team to develop collegial and mutually productive relationships with CMC team members. This position utilizes CMC technical knowledge and regulatory expertise to drive internal consistency and influence effective change management. This team will be expected to influence and execute regulatory strategies that can accelerate the development of assigned project(s).Job Responsibilities:Leads preparation, technical and regulatory review and finalization of CMC sections for global CTA submissions and response to questions.Takes a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content. Makes technical decisions on CMC regulatory issues impacting product submissions across geographies, with support or guidance from Client GRA-CMC regulatory scientists.Networks and gains alignment with CMC team members and GRA-CMC regulatory scientists to resolve complex issues.Assists in the development of regulatory strategy and update strategy based upon global regulatory changesProvide high quality, timely and clear regulatory advice to allow CMC teams to make well-informed decisionsEvaluate regulatory impact on proposed CMC development plansAnticipates and resolves key technical or operational issues that can impact the function or CMC team.Participates in risk-benefit analysis for regulatory compliance.Develop relationships with CMC team members that promote open discussion of issues to enable regulatory influence of drug development strategies.Communicates effectively verbally and in writing to influence within GRA-CMC and with CMC development team.Demonstrated negotiation and influence skills. Demonstrated effective teamwork skills, able to adapt to diverse interpersonal styles.Proactively identifies and resolves global CMC regulatory issues.Partners with Client GRA CMC (regulatory scientists) develop complex regulatory strategies.Partners with Client RDE (regulatory associates/publishing group) to ensure completion of submission activities.