Change Management Specialist

European Medicines Agency; Amsterdam; On-site; EUR 60,000 - 80,000; Full time

Job summary

A key regulatory body in Europe is seeking a Change Management Specialist to lead the implementation of new pharmaceutical legislation. You will be responsible for creating a strategic framework to facilitate the adoption of transformative changes across the European regulatory network. Ideal candidates should have extensive experience in regulated industries, strong strategic analysis skills, and knowledge of digital transformation. This role is pivotal in enhancing the efficiency and competitiveness of medicines regulation in the EU.

Qualifications

• C1 level English and B2 in another EU language required.
• At least 3 years professional experience, 2 in regulated industries.

Responsibilities

• Lead the change management programme for legislative implementation.
• Create a strategic framework for stakeholders to adopt changes.

Skills

Strategic analysis frameworks

Business impact assessment

Digital transformation

Regulatory knowledge

Education

University degree (minimum of three years)

Job description

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The revision of the European pharmaceutical legislation is a unique opportunity to reshape medicines regulation in the EU and make the EU regulatory framework more fit for innovative medicines, to promote greater access to medicines for patients and to address the major public health challenges of the future (e.g. antimicrobial resistance).

The new pharmaceutical legislation will simplify structures and procedures which have been introduced by different pieces of legislation over the years. A simplified and more integrated regulatory system will be easier to navigate for developers and aims to make Europe more attractive and competitive in the global environment.

The revised legislation will also reduce administrative burden, to help improve sustainability of the European medicines network, rationalise the use of the scientific assessment resources in the network, and become more agile in dealing with complex medicine assessments.

About the position:

In this context, EMA is looking for a Change Management Specialist with intra organisational and extra organisational change management capabilities to reinforce the team coordinating the implementation of this legislation.

The Change Management Specialist will be responsible for leading the change management programme to implement the new European pharmaceutical legislation as part of EMA’s implementation team. The change management specialist will create and implement a responsive strategic framework to enable EMA, the European medicines regulatory network, industry and other stakeholders to successfully adopt the transformational changes resulting from the new European pharmaceutical legislation.

Eligibility requirements:

1. enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein or Norway;

2. have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2);

3. have fulfilled any obligations imposed by applicable laws concerning military service.

Specific conditions:

1. possess a university degree (minimum of three years) that must have been obtained by the closing date of this vacancy notice, and at least 3 years of professional experience after obtaining the relevant degree, that must have been obtained by the closing date.

You will also need to have:

Experience

Out of the 3 years of experience listed under Specific Conditions (Eligibility criteria) a minimum of 2 years of experience in regulated industries (pharmaceuticals, medical devices, healthcare strongly preferred) managing business change in complex multi-stakeholder regulated environments.

Skills and Knowledge

• Solid understanding of applying recognised strategic analysis frameworks (e.g. SWOT analysis, value chain analysis) to assess organisational challenges and opportunities;
• Working knowledge of assessing and quantifying the business impact of change initiatives across multiple organisational functions and stakeholders;
• Good understanding of digital transformation concepts and their application to organisational change;
• Basic knowledge of the lifecycle of medicines and the regulation of medicines in the EU or in other highly regulated industries and its multi-stakeholder ecosystem.

Certificates

• Professional certification in change management from a recognised training organisation.

We are an equal opportunities employer.