Senior Manager – Global Emerging Markets GSRS

Member of regulatory project team(s) representing the Global Emerging markets primarily for 1-3 marketed products. Responsible for ensuring availability of contemporary regulatory documentation to support new submission and lifecyle management activities Provides regulatory support to GEM regional leads including submissions for NCE /NME. Responsibility for providing GEM strategic input for early development compound as member of regulatory project team (RPT)

Accountability Description

• Manages the communication, development and implementation of Global Emerging Market strategies for Safety Updates for assigned products across 4 regions (LATAM, CEE, APAC and MENA). Working closely with Regional Regulatory Leads
• Accountable and responsible for delivery of regulatory strategy for Assigned products in CEER and MENA regions, working closely with partner and affiliate counter parts, supply chain, commercial and medical colleagues where required to determine optimal strategy to ensure supply continuity and patient safety. Ensuring delivery of agreed strategy to the timelines agreed.
• Provides regulatory support for NCE/NME submissions in assigned regions/markets (CEER and MENA) developing and agreeing submission strategy and timelines, liaising closely with external CRO to ensure delivery to agreed strategy/timelines
• Product lead and member of Regulatory Project Team / Asset Team for 1-3 established product, provides consolidated Global Emerging Markets input and insight into the team, to ensure GEM has a “voice” within the organization and to ensure GEM strategy is developed in parallel and in alignment with EU/US strategies. To be a counterpoint in EU / US centric RPTS.
• Product lead for at least one Development Product from Phase 2, as above provides consolidated Global Emerging Markets input and insight into development teams, to ensure GEM has a “voice” within the organization and to ensure GEM strategy is developed in parallel and in alignment with EU/US strategies. To be a counterpoint in EU / US centric RPTS. Working closely with GEM regional leads, drives the development of Regulatory strategy in the regions, responsible for gaining agreement for submission timelines in the markets with the ASSET team and ensuring submissions are made to the timelines agreed, working through GEM regional colleagues
• As all colleagues, managing day to day issues which arise as a result of misunderstanding in systems and process, firefighting issues which arise due to market issues and asset driven issues with supply chain. Taking time to review root cause and proposing/looking for improvements to our current systems and process, to improve our performance and consolidate GEM within the global organisation
• Minimum 3-5+ years pharmaceutical/biotechnology industry experience in International/Regulatory Emerging Markets
• Skills and experience to represent the GEM group on project teams.
• Experience and knowledge in the preparation of major regulatory su

Our new Senior Manager will be responsible for driving development and implementation of Global Emerging Market (GEM) regulatory strategies for legacy registration submissions and lifecycle management activities across four regions (LATAM, ASIA, CEE, MENA).