Formulation Scientist
This job is no longer available
There are still lots of open positions. Let's find the one that's right for you.
About The Position
If you're experienced in pharmaceutical formulations or chemistry manufacturing and controls, but you're interested in taking your career into a non-lab, regulatory affairs space, this is a great opportunity for a career pivot! The position involves leading the preparation, technical, and regulatory review and finalization of CMC sections for global CTA submissions. You will take a proactive role in the critical review of molecule specific GRA-CMC development strategies and submission content, making technical decisions on CMC regulatory issues impacting product submissions across geographies, with support or guidance from Client GRA-CMC regulatory scientists. The role requires providing high quality, timely and clear regulatory advice to allow CMC teams to make well-informed decisions, evaluating regulatory impact on proposed CMC development plans, and communicating effectively verbally and in writing to influence within GRA-CMC and with the CMC development team. You will partner with Client GRA CMC (regulatory scientists) to develop complex regulatory strategies and with Client RDE (regulatory associates/publishing group) to ensure completion of submission activities.
