A career 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.
An exciting new opportunity has arisen to join Merck as Regulatory Project Manager. In close collaboration with the International or Marketed Product Lead. you are accountable for the operational aspects of regulatory deliverables for international rollout and/or lifecycle management. As a member of the regulatory sub team you represent Regulatory Operations in the Regulatory Sub Team. 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.
As a Regulatory Project Manager, you are reporting to the Head of Marketed Product Regulatory Project Management who is based in GRA Operations.
Who you are:
- 4-6 or more years’ experience in pharmaceutical industry, with 3 years of regulatory or regulatory operations experience, or equivalent.
- In-depth knowledge of the Regulatory Operations area, including processes and technology solutions.
- 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.
Department: RD-RAP-P RPSM Development Products
Job Evaluation: AT / Level 3
What we offer: 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!
Curious? Apply and find more information at https://jobs.vibrantm.com