Director, Regulatory Affairs Global Lead UK/EU

Director, Regulatory Affairs Global Lead UK/EU

Kyowa Kirin International

Paris, Düsseldorf, Milan, Amsterdam, Madrid or United Kingdom

Job Purpose

As Global Regulatory Lead (GRL), responsible for leading the development and delivery of innovative global regulatory strategies for an assigned global product. Oversight of global regulatory activities (where appropriate), including development activities (e.g., clinical trials, paediatric plans), agency interactions, marketing applications and maintenance/life-cycle management activities, based on global plans. Provides leadership of the Global Regulatory Affairs Functional Team (RAFT) and contributes to global product strategy and execution plan development with relevant cross functional team e.g., Global Product Franchise, Global Project Team.

In addition, act as Head of Marketing Products for the European Economic Area (EEA) [including UK and Switzerland] within Global Regulatory Affairs; managing a small regulatory team responsible for EEA product lifecycle management.

Responsibilities

• GRL for an approved global product and provides leadership of the global RAFT, including support for the Regional Regulatory Leads (RRLs) to achieve their agreed objectives;
• Head of Marketing Products for the EEA ([including UK and Switzerland), line managing a small regulatory team based in the EMEA region who manage marketing products;
• Lead the creation and maintenance of global product regulatory strategy at all lifecycle stages in collaboration with RRLs and, consulting with appropriate stakeholders and functions where necessary; to ensure the highest quality strategic regulatory input is provided to optimise regulatory outcomes and maximise product value in line with company strategy;
• Identify and assess regulatory risks associated with product development and lifecycle management and define strategies/ countermeasures to mitigate risks and escalate risks where needed;
• Provide the one team voice for the Global RAFT in communicating regulatory information and strategic recommendations into global cross functional teams (commercial and development), and those functions associated with product strategy;
• Responsible for working with the RRLs to set and track RAFT objectives/KPIs, project RA resourcing and RA finance activities (as required) in line with the Company objectives and in agreement with the Global/Regional/Functional Head of RA;
• Oversee the management of meetings with Regulatory Agencies across regions, including where appropriate the generation of master briefing documents, to ensure alignment with the global strategy;
• Oversee the strategy, management, and production of regulatory submissions across regions, including development applications (e.g., clinical trials, paediatric plans), agency interactions, marketing authorisations, maintenance/life-cycle management activities, to ensure timely submissions according to plan and ensure alignment with the global RA strategy;
• Support RRLs to ensure maintenance of and compliance with marketing authorisations, including follow-up of commitments as a condition of approval;
• Keep abreast of key legislation and guidelines associated with Product appropriate for global role;
• Develop early regulatory strategy, acting as Global/Regional/Western Regulatory Lead for early phase development project(s) as needed;
• Provide Global RA support for regulatory activities associated with partnering activities, including due diligence for in- and out-licensing activities;
• Ensure effective global communications to RAFT for onward communication to Competent Authorities, licensing partners and country contacts, etc. in line with the Global RA strategy;
• Ensure improvement on operations when operational issues are identified, with cooperation among Global Franchise, Development Project Team and/or Regulatory Function members;
• Responsible for oversite of the LCM activities (deliverables and compliance) for the products registered in the EEA;
• Line manage RRL and Regulatory Support Staff;
• Provide RA support for GxP inspections as required;
• Ensure compliance as one global Kyowa Kirin.

Qualifications

• Life science qualification with significant experience in pharmaceutical regulatory affairs;
• Expert post-marketing regulatory knowledge in the global regulatory environment and experience leading global regulatory strategy for products in lifecycle management, having experience working as a Global Regulatory Lead (GRL) or similar strategic regulatory role;
• Capable of leading and managing staff.

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