Senior Formulations Scientist

Position Overview:This position will provide strategic, tactical, and operational direction and support to expedite development of our client’s clinical trial portfolio by helping to develop successful regulatory strategies and submissions in support of clinical trials. This position utilizes CMC technical knowledge 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:Include but are not limited to:Leads preparation, technical, and regulatory review and finalization of CMC sections for global CTA submissionsTakes a proactive role in the critical review of molecule specific GRA-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.Provide high quality, timely and clear regulatory advice to allow CMC teams to make well-informed decisionsEvaluate regulatory impact on proposed CMC development plansCommunicates effectively verbally and in writing to influence within GRA-CMC and with CMC development team.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.