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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 th