Regulatory Project Manager - Development Projects (all genders)

Posted on Apr 17, 2019 by Merck KGaA

Darmstadt, Hessen Germany
Health Care
15 Apr 2019
Annual Salary
Full-Time
Regulatory Project Manager (all genders)
A career at Merck is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. Activities and responsibilities An exciting new opportunity has arisen to join our company as Regulatory Project Manager. In close collaboration with the Global Regulatory Strategist you are accountable for the operational aspects of regulatory deliverables within Pipeline Projects (LCM projects or Development Projects. As a member of the regulatory sub team you plan, manage, track and ensure on-time production of regulatory deliverables for all submissions. As the leader of the Submission Taskforce you lead a cross functional team ensuring delivering of all dossier components, review and approval for submissions and coordinating the response to questions. As subject matter expert in the Global Project Team you provide timelines, direct cost demand and dashboards for Global Regulatory Affairs.
You coach junior regulatory project managers and actively participate to the development of competences within the Regulatory Affairs project manager community. Who you are: Several years experience in the pharmaceutical industry, with 6 years of regulatory or regulatory operations experience, or equivalent.
Thorough understanding of the Regulatory Operations area, including processes and technology solutions.
Demonstrated experience in dossier creation and submission in US, EU and intl. countries.
Strong project management skills/experience, international project experience.
High attention to detail and strong organizational skills, work independently, self-motivated and proactive.
Ability to establish close communications and working relationship with cross functional teams to meet business objectives
Ability to work with uncertainties and effect innovative solutions to complex regulatory requirements
Strong negotiating, influencing and interpersonal skills especially regarding indirect people leadership in a matrix organization.
What we offer: At Merck, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Reference: 694604511

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