Managing a team of RA Associates that are responsible for compiling and maintaining the CMC part (modules 2 and 3) of medicinal product dossiers for the worldwide registrations of the products handled by the Site RA (SRA) Pillar team.
Roles & Responsibilities
plan Departmental activities, and ensure that they are adequately delegated and that the required resources are available. Directly coordinate and prioritize daily activities of the assigned staff;
supervise and coach SRA Associates in their duties and also handle the allocated portfolio, the main tasks being:
actively participate in the change control system and the RA strategy related to CMC changes;
actively participate to the improvement or at least maintenance of the compliance status of the dossiers;
keep track of the variation status and update the relevant departments accordingly;
be responsible for renewal/annual reports applications preparation;
maintaining the dossiers, in order to reflect the latest regulatory status;
providing answers to module 3 questions from Health Authorities, handling respective deficiency letters, supporting foreign representatives and 3rd parties and maintaining good contacts with external parties;
providing assistance in the technical transfer of products.
monitor and report on departmental Key Performance Indicators;
identifying process improvements and making proposals for their implementation;
representing Site Regulatory Affairs in (multi-disciplinary) project teams;
recruit staff as necessary;
ensure that all SRA Associates are adequately trained and well informed as to their role, duties and responsibilities.
University degree - Chemistry, Chemical technology, Pharmacy or other related field;
minimum 5 years of relevant EU/international Regulatory Affairs experience;
we will also consider candidates with less experience than mentioned;
prior collaboration with FDA, knowledge of ANDA fillings and combination product experience is preferred;