Manager, Regulatory Affairs Immunology - United Kingdom
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- 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 company’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 our company fulfills 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.
- Bachelor’s degree in scientific discipline or equivalent required.
- Experience in EU Regulatory Affairs & recent experience of EU Centralized Procedure required.
- Good understanding of current regulatory requirements essential
- Good understanding of CTD modules; non-clinical, CMC, Clinical
- Thorough understanding of core processes of drug discovery, development, manufacturing & marketing required.
- Developing understanding of TA for projects assigned
- Experience in Inflammation/ Immunology preferred
- Able to contribute to Ph III protocols & clinical development plans.
- Takes initiative for professional development
- Seeks opportunities to learn from others
- Effective project manager. Prioritizes 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