Global Head of Regulatory International

Vor 4 Tagen

Darmstadt, Deutschland Merck KGaA Darmstadt Germany Vollzeit

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

**Your role**: As Head of International Regulatory Affairs you will oversee regulatory activities for our pipeline in international markets. All countries regulatory staff will report into this position through their regional heads in Europe, Canada, Latin America, MEAR and APAC. You will provide strategic input for the global development, licensure and life cycle management of the pipeline, working closely with local health authorities to manage submissions and other agency related queries. The position closely partners with Global Regulatory Affair (GRA) leaders and other cross-functional leaders (ie. commercial, medical, operations etc) to provide strategic guidance regarding the impact of regulatory issues on corporate strategy and operations for the regions. This position reports to the Senior Vice President, Head of Global Regulatory, R&D Quality and Safety (RQS), and is one of the integral members of the RQS leadership team; the role also represents GRA on the commercial leadership team and other governance related forums.

**Key responsibilities**
- Responsible for managing and leading multi-disciplinary teams to achieve project and business goals per timelines
- Provides effective regulatory guidance to the company's research and development organization, helps identify regulatory risks and resolutions, and develops effective regulatory strategies to help efficiently advance and maintain pipeline drug products. Act as senior company representative vis a vis Health agencies
- Keeps current on International regulatory developments and changes in reg policies/ requirements to advise on impact on company business and to develop appropriate response plans
- Assesses country and regional-specific regulations/requirements, and develops proactive regulatory plans and strategies, aligned with business goals, to expedited development of the company's proprietary products towards commercialization
- Helps design the infrastructure of the Regulatory Affairs Department, including SOPs and implementation of process improvements, to enhance the efficiency of operations at local/ regional level
- Ultimate responsibility for submissions/approvals and regulatory contribution to marketing products in all affiliates where we operates (ex-US). The overall sales business supported is in the range of 5.5 Billion₠

**Who you are**
- At least 15 years in multinational Pharma companies with min 13 years in Global Regulatory Affairs; Preferably 10 years in leadership position.
- R&D background
- Established experience of International Regulatory requirements and practices
- Demonstrated experience on ability to interact with Regulatory bodies and external partners
- Demonstrated track record of success in similar positions
- Demonstrated senior leadership attributes
- Gravitas to negotiate within a highly demanding environment to deliver complex messages and take appropriate decisions, ability to network with leaders in related functions: Commercial, Manufacturing, Medical, Clinical, Market Access....
- Ability to adhere to strict project timelines and budgets, and to advise teams and management of impacts and changes in project timelines
- Ability to manage changing priorities, evaluate impact, and communicate timeline and resource impacts to project teams and management is required
- Must be experienced in staff and organizational development, motivating personnel / teams, and providing effective coaching, training and development
- Communicate with clarity, impact, and passion

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a

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