We are looking for an experienced Associate Director in Regulatory Affairs CMC (RA CMC) for one of the late stage projects approaching Life Cycle Management (LCM). You will work closely together with two other colleagues in RA CMC. You will as a team be responsible for the transition of the product from a development project to a marketed product in LCM. In addition, you will be overall RA CMC responsible for the ongoing clinical trials in phase III, be involved in marketing authorization submissions in new countries and handle CMC variations as agreed within the RA project team.
As Associate Director in RA CMC you will report to the Director of RA CMC and be part of the RA CMC team, currently consisting of six very experienced RA CMC colleagues.
You will work closely together with experienced colleagues in regulatory, CMC development, product supply and quality assurance in this product transition process from development to LCM ie you will have many stakeholder interactions on a day to day basis.
The successful applicant will have a proven record with LCM experience and submission of MAA’s globally and you have at least seven years of documented professional experience from a regulatory affairs CMC position in the Pharma industry. In order to be successful in this position you should also have experience with handling of INDs, CTAs in late phase development.
You hold a Master’s degree within Natural Science or a related field. You are proficient in English at a professional level, both written and spoken.
You have excellent collaboration and communication skills. You work well independently for the success of your projects and you are skilled in conflict resolution with strong negotiating skills and ability to think creatively and develop creative solutions. You have a proven ability to build trust and respect within the organization and you are highly committed to deliver outstanding results. Finally, you have a hands-on attitude, professional work ethic and you are teamwork oriented. Finally, you meet the overall goals and timelines for the projects you are involved in.