Regulatory Affairs Lifecycle Process Coordinator

We are looking for an enthusiastic Regulatory Affairs Lifecycle Process Coordinator to join our dynamic Adalvo team. This position offers an opportunity to well-suited candidates to join a growing, fast paced energetic environment and culture.

SUMMARY OF POSITION

The Regulatory Affairs Lifecycle Process Coordinator is responsible for ensuring compliance with applicable laws, regulations, and guidelines to facilitate the approval of all post approval activities of products.

ORGANIZATION STRUCTURE

The role reports directly to Director, Operational Regulatory Affairs and is located in Portugal.

RESPONSIBILITIES

Primary responsibilities of this role include the following :

• Provide the highest quality advice on regulatory issues to team members by maintaining awareness of current regulatory legislation, guidance and practice related to post approval activities.
• Able to assess the technical complexities, scientific challenges, and regulatory landscape with full accountability to the end business requirements.
• Address complex and diverse challenges with decision-making that impacts launches / replenishment orders;
• Proactively engage in all post-approval activities to ensure project deliverables are met and to overcome regulatory enquiries. This includes quality check of submission packages by identifying, highlighting and resolving issues where necessary;
• Initiate improvements to enhance the efficiency and the quality of work performed by lifecycle management team;
• Initiate, coordinate and track variations, renewals and MA transfers for the assigned medicinal products, approved through European procedures (MRP, DCP, CP) or national submissions across all regions of interest
• Inform all involved departments on the status and progress of the assigned projects, so that objectives are met, any potential issue is identified and solutions are being found
• Compile, verify and publish submissions using electronic publishing software considering the submission deadlines and technical requirements on management of dossiers lifecycle.
• Ensure a stronger compliance on data and knowledge management.

QUALIFICATIONS & REQUIREMENTS

CORE COMPETENCIES