Contributes to the initial development, execution & delivery of EU regulatory strategy for projects assigned. Responsible for the building of regulatory dossiers to achieve timely regulatory approvals & maintenance of the existing product portfolio. Liaises with Regulatory Strategy Leader, Regulatory Affairs (RA) Projects Team management & with other internal/external stakeholders.
Contributes to the execution of development & submission strategies in EU for projects assigned.
Works with Regulatory Strategy Leader & Regulatory Projects Team leadership to ensure that development programs & product life-cycle plans are aligned with regulatory requirements.
Contributes to the assessment of the pros, cons & risks associated with regional strategic options for projects assigned.
Contributes ideas to the design of innovative regulatory pathways.
Supports Regulatory Projects Team Leadership on development of regulatory tactics to be communicated to internal stakeholders, e.g. Global Project Team as requested
May interface between global & regional headquarters to ensure both parties are kept updated on regulatory progress & operational issues & may participate in global regulatory therapeutic area (TA) team.
May develop or contribute to the development of high quality regulatory dossiers (e.g., scientific advice requests, orphan medicinal product designation applications, MAAs & variations), ensuring compliance with regulatory requirements.
Develops content of regulatory documents working with other functions as necessary & contributes to the review of documents before submission.
Reviews draft protocols, acts as Regulatory Project Team representative in clinical study teams & liaises with the Clinical Trials Applications (CTA) group.
May act as subject matter expert on designated studies in the event of a Health Authority inspection
Responsible for the delivery of Content Plans to allow publishing & timely dossier submission.
Responsible for tracking & communicating regulatory activities within RA & responsible for accurate submission plans in eQRMS
Identifies & communicates to manager, any emerging issues that may impact Celgene’s business.
May participate in interactions with Regulatory Authorities, including agency meetings.
Supports the optimisation of product information achieved through negotiation with internal stakeholders & Regulatory Authorities.
Supports activities to ensure that Celgene fulfils Health Authority commitments.
May participate in regional launch team
May be responsible for the regulatory review & approval of commercial advertising & promotional literature
Highlights resource constraints through discussion with manager.
Identifies any learning or best practice & communicates to manager.
Responsible for maintaining knowledge of current EU regulatory guidance & procedures
May participate in cross-functional initiatives.
International travel may be necessary.
Takes initiative for professional development
Seeks opportunities to learn from others
Effective project manager. Prioritises tasks appropriately. Able to & coordinate the delivery of multiple projects
Ability to lead routine regulatory submissions. Leads activities for assigned projects
Demonstrates appropriate decision making
Displays a willingness to challenge the status quo & take risks & acknowledges others who take the initiative to try new approaches even if the results are not perfect
Can identify when to escalate issues to line management & knows when to seek advice.
Communicates complex ideas effectively across a culturally diverse environment
Communicates effectively with Regulatory Authorities when tasks have been delegated
Obtains alignment through effective communication
Ability to influence internal stakeholders
Exhibits consistent professional behaviours