Site Name: GSK HQ Posted Date: Nov 12 2024 Location: London Job Purpose : To lead regulatory strategy, governance and operations for the European Partnership Markets - total number of markets 16 (Romania, Bulgaria, Hungary, Slovakia, Slovenia, Serbia, Croatia, Estonia, Latvia, Lithuania, Cyprus, Malta, Bosnia, North Macedonia, Albania, Montenegro), including coordination of aligned Global Regulatory Content Delivery (CD) team activities and oversight of 3rd party partners and outsourced MAH responsibilities for non-EU countries (Serbia, Bosnia, North Macedonia, Montenegro). In addition: Further development and maintenance of standardized internal control framework in the European Partnership Markets Line management, coaching and development of the team Be an authority on the regulatory framework in the Euopean Partnership Markets (with support from local point of contact as required) to provide guidance to the local business to ensure compliance and support commercial growth Key Responsibilities Lead regulatory strategy to underpin the Pharmaceutical business in the Europeam Partnership Markets to support competitive license approvals, market access, product launch and supply continuity Leadership and coordination of regulatory affairs activities completed in operational matrix (Partnership Team, Global CD and 3rd party Partner), for product portfolio in the European Partnership Markets Third-party contract owner, and responsible for governance and oversight, including accountability for audit program and issue escalation Builds, maintains and leads an efficient and well motivated team ensuring appropriate prioritisation and flexible resourcing including driving and measuring performance Leads the resource management, objective setting and review, development and coaching of staff. European Partnership Markets Regulatory representation on key projects and strategic initiatives Ensure the development and optimisation of standardized, efficient and compliant processes across the European Partnership Markets Leads regulatory risk management for the European Partnership markets. Ensures responsibilities relating to regulatory conformance are adhered to. Regulatory Lead at audits and inspections. Leads issue management activities as appropriate Builds and maintains effective relationships with internal regulatory, quality, commercial, & supply chain groups. Why you? Knowledge/ Education / Previous Experience Required Educational Background Degree or masters/ PhD in scientific discipline, additional education in leadership is beneficial Area of specialization: Life Sciences / Pharmacy / professions aligned to medicine Job-Related Experience At least 10 years of relevant industry experience in Regulatory Affairs of which a considerable part has been in leadership positions. Experience of leading effectively at senior levels and in a matrix across functions local operating company experience is required Other Job-Related Skills/Background : Knowledge of regulatory specifics Knowledge of the policies and regulatory climate in Europe A proven track record of effective collaboration and negotiation with regulatory agencies The ability to recognise, anticipate and discuss potential regulatory challenges with teams in the Business and Global Regulatory. High degree of comfort and positive engagement working as a member of a multifunctional team, in a leadership role or as a senior contributing member; Leadership Expectations Experienced in strategic interface with global functions and senior stakeholders Strong management and project leadership skills, ability to provide advice and counsel to company staff in strategic decisions; Well-developed and demonstrable leadership skills. The ability to make decisions/influence outcomes that include assessment of the risk and impact on the business and using good judgment regarding when to refer issues to senior management; A competent and transparent communicator with excellent written, verbal and presentation skills The ability to make decisions/influence outcomes that include assessment of the risk and impact on the business and using good judgment regarding when to refer issues to senior management; A competent, complete, and transparent communicator with excellent written, verbal and presentation skills. Ability to manage conflict in a consensus building manner showing sensitivity to building productive business relationships; demonstrates excellent ability to have conversations in which there may be varying and different opinions or approaches/options. Leading across the area to coach and mentor staff. Managing 3rd party vendors CLOSING DATE for applications: 16 November 2024 When applying for this role, please download your CV in English + a cover letter to describe how you meet the competencies for this role. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. 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