... worldwide technical expert, on relevant regulatory issues potentially impacting the study. ... timelines, the 1-5 year regulatory studies and activities budget, specifying ... supervise, train and mentor junior regulatory affairs team members, including providing ...
... cross-functional teams, ensuring that regulatory submissions comply with local and ... attention to detail. Proficiency in regulatory submission tools and databases. Ability ... growth and advancement within the regulatory affairs field. Exposure to innovative ...
... of experience in regulatory affairs in the pharmaceutical, biotechnology, ... successful interactions with regulatory authorities. Strong leadership and management ... and convincingly present regulatory strategies and perspectives. Strong organizational ...
... a subject matter expert in regulatory processes, laws, and regulations, with a comprehensive understanding of how regulatory policy is shaped and developed ... , assessment, and communication of global regulatory changes to all stakeholders. Ready ...
... these dossiers to the appropriate regulatory authorities (e. g. Paul-Ehrlich- ... relevant experience in European pharmaceutical Regulatory Affairs, ideally in biological products ... of German national and EU regulatory requirements and laws. You have ...
... standards Life-Cycle Management: Manage regulatory life-cycle activities, including renewals, ... of professional experience dealing with regulatory affairs aspects within the pharmaceutical ...
... for planning, coordinating, and overseeing regulatory submissions required for maintaining marketing ... , supporting the development of global regulatory strategies. Furthermore, you will act ...
... lead and develop our Global Regulatory Operations team and be responsible ... creation, filing and reporting of regulatory submissions. In this role, you ...
... . Within BU SoBa, the Market Regulatory Expert plays a vital role ... SoBa to stay ahead of regulatory changes and seize opportunities within ... and renewables. Previous engagement with regulatory bodies or lobbying activities is ...
... the Bank); ·Contribute to the regulatory watch; ·Supervise Regulatory Compliance topics, especially in the ... experience in project management and regulatory changes ·Ability to apply risk ...