Regulatory Affairs Manager (f/m/d)

• Randstad is one of the world's leading talent companies with the
• ambition to be the world's most equitable and specialized talent
• company. Through our "partner for talent" corporate strategy, we find,
• develop and connect specialized talents with companies - worldwide,
• locally and always at a high speed. We build high-quality, diverse,
• and agile teams, while individuals can enjoy a rewarding career path
• with equitable opportunities.
• Randstad Professional is one of Randstad's four specializations
• and focuses on the placement of specialists and managers in the
• future-oriented sectors of IT, Engineering, Life Science and Office.
• Time for change – time for a new job! You are a regulatory affairs
• specialist and looking for a new professional challenge? Then stop
• searching! We offer the job you are looking for: We offer a secure
• job, fair compensation and exciting new tasks at an
• attractive pharmaceutical company in Ludwigshafen. Apply online
• now! We welcome applications from all suitably qualified persons
• regardless of any disabilities.

• Provide support to complete product dossiers, technical files and

responses to information requests

• Coordinate and complete documents required by federal agencies,

• incl. maintaining complex files and electronic document management
• systems

• Work with project teams to obtain approval for company products
• Serve as the primary point of contact for federal governmental

• agencies, embassies and consulates in Germany and function as center
• of excellence for requests

• Gather documents from all EU facilities required for product

registration in applicable countries/regions

• Coordinate document requests for products approved via the

Centralized Procedure (CP) but are manufactured in Germany

• Work directly with third party manufacturing companies to obtain

documents

• Bachelor's degree in life science, clinical research studies or

engineering, ideally with previous regulatory experience

• Several years of experience in a regulated business environment

(e.g. legal office, regulated industry)

• Experience working with Microsoft Office suite, most notably with

Excel, Word, Outlook, Teams, and Microsoft SharePoint tools

• Working knowledge of database management
• Knowledge on current policies and practices issued by local German

federal agencies

• Awareness on regulatory policies/procedures to learn and better

understand how the landscape of regulations develops

• Good proficiency in the English language
• Strong negotiation and communication skills as well as ability to

organize data and identify issues or gaps in documentation

• Above-average salary
• Extensive social benefits, incl. Christmas and holiday bonuses
• Up to 30 days vacation per year
• Company pension scheme contribution after the end of the

probationary period

• A wide range of employee benefits/perks