Regulatory Affairs Manager (f/m/d) (Regulatory-Affairs-Manager/in)

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