Director, Regulatory Project Management
$135.3k - $202.9kMerck Group
Work Your Magic with us! Start your next chapter and join EMD Electronics.
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. Everything we do in EMD Electronics is to help us deliver on our purpose of being the company behind the companies, advancing digital living. We are dedicated to being the trusted supplier of high-tech materials, services and specialty chemicals for the electronics, automotive and cosmetics industries. We foster a global collaborative organization made up of individuals who have the passion to win, obsess about the customer, are relentlessly curious and act with urgency. Together, we push the boundaries of science to make more possible for our customers. Global Regulatory Project Manager We are seeking a Director, Regulatory Project Manager to lead the end-to-end planning and execution of global regulatory submissions to Health Authorities. In this role, you will translate regulatory strategy into actionable plans, drive cross-functional alignment, and ensure submission deliverables are completed on time, with quality, and in compliance -even in fast-moving, high-impact situations. You will partner closely with Regulatory Leadership and Submission Management, lead submission task forces, proactively manage risks and dependencies, and provide clear, confident communication to stakeholders up to senior leadership. What you will do- Plan and track global regulatory deliverables for submissions worldwide (e.g., CTA/IND, MAA/NDA/BLA , major HA interactions such as Scientific Advice/meetings).
- Build and maintain integrated project plans , timelines, and critical path views; ensure clarity on scope, deliverables, owners, and dependencies.
- Lead and run Submission Task Forces for initial applications; co-chair international submission taskforces supporting global rollout of new assets.
- Drive issue resolution and "crisis" intervention to protect timelines; set up enhanced hyper-care support for critical submissions.
- Own risk and stakeholder management : surface risks early, communicate impacts transparently, and align mitigation plans with key partners.
- Coordinate resource and budget planning for Regulatory activities; consolidate budget demand and serve as key contact to Global Project Management and project controlling.
- Strengthen execution through continuous improvement of project management tools, templates, and ways of working to meet Health Authority requirements.
- Act as a senior advisor/mentor , influencing across functions and contributing to operational and strategic decisions in regulatory project management.
- Advanced degree (e.g., PhD, PharmD, MD, or equivalent).
- At least 6 years of project management experience in drug development and regulatory affairs.
- Demonstrated ability to lead in a matrixed environment and coordinate multi-disciplinary teams.
- Strong written and spoken English; proficiency in additional languages is a plus.
Vacancy posted 2 hours ago
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