Are you a hands-on qualified regulatory affairs professional with an interest for nephrology and urology? Are you able to play a key role in an international organization and influence and coordinate strategy in this challenging role within regulatory affairs? Then Astellas has an interesting job opportunity for you!
Associate Director Regulatory Affairs
Fulltime, 40 hours, Leiden, The Netherlands
This position plays a key role in the regulatory affairs department. You are responsible for defining EMEA regional regulatory strategy for development compounds and life cycle management and can be a member of several project teams. You are a regulatory project leader who drives development, maintenance and submission related activities and you execute product regulatory strategies successfully.
The role is highly analytical and complex; you work on strategic, diverse problems, with decision making that has functional or corporate impact. You need to influence and communicate clearly, as actions may have serious implications on operations, revenue, and/or credibility. In this position you anticipate regulatory issues for assigned projects and manage them proactively.
As an associate director you are a senior regional regulatory leader who works in multifunctional project teams. Astellas Pharma is a global organization; you will interact with people from other disciplines involved in drug development and LCM. You to be able to work independently and as part of a team.
You will work in the Specialty Medicine therapeutic area with focus on nephrology and urology compounds/medicines and you provide expertise in directing projects within these therapeutic fields. The role includes contact with Regulatory Affairs and Operations Medical Affairs, Legal, Commercial, Market Assess, Clinical Research and Development, Chemistry Manufacturing and Controls (CMC), Advertising/Labeling, and the extended Global Project Teams.
You have strong organizational skills with the ability to manage large a diverse workload and provide regulatory guidance/training to others. As a multitasker you have the ability to communicate effectively and maintain effective working relationships. You must be able to have a positive influence on the department staff and behave with a high integrity. The role requires excellent and oral communication skills