Project Description For our RA CMC department we have a large COVID-19 project that we need support on. The main focus will be on vaccines, but flexibility to be put to work on other dossiers may be needed.
Support to the Chemical, Manufacturing and Controls Regulatory Affairs (CMC RA) group
GOAL:
Obtaining global registrations in > 140 countries and assuring regulatory approvals for supply capacity expansion (in total at least >15 manufacturing sites)
TIMELINES:
regulatory approvals according to organizational plan, major countries (including WHO) in 2021, additional countries in 2022
capacity expansion according to the need (> 10 new manufacturing sites approved in 2021)
About the department
The primary responsibility is to support the regulatory activities related to vaccines in all global markets, and could be extended to small molecules as well. Support CMC Teams and provide direction on the interpretation and application of global CMC regulations and guidance related to vaccines. Additional responsibilities include: contribute to the preparation and editing of clinical trial and marketing applications including post-approval changes; correspondence and direct interaction with Health Authorities; development of product-specific regulatory strategy documents; technical review and approval of master protocols, reports and other source documents; and other related duties as assigned.
Experience requirements
Direct and significant regulatory experience with vaccines and in CMC documentation preparation for late phase INDs and IMPDs, BLAs and MAAs, and post-approval submissions for vaccines highly preferred.
Strong knowledge of EU and FDA regulations is required, experience with other markets is added value.
Experience in supporting Health Authority meetings (FDA, EMA and national agencies) preferred.
Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required.
Strong interpersonal, teamwork, leadership, conflict management, fast learner and negotiation skills are essential. The candidate must be able to manage and motivate people within a matrix team environment and as an individual contributor, decision maker, and leader.
Project management role:
Keep global overview of submissions done/approvals including details on key info included in the approval
Make planning for all upcoming submissions including:
Submissions for first registrations including content overview of the dossiers
Submissions for expansion of supply capacity including content overview of the dossiers
Commitments made with the already obtained approvals and timing for submitting this info