Regulatory Affairs Specialist
vor 1 Woche
We are seeking a highly skilled Regulatory Affairs Manager to join our team at GULP – experts united. As a key member of our organization, you will play a crucial role in ensuring compliance with regulatory requirements and facilitating the registration and marketing of our products internationally.
Key Responsibilities:- Provide support in the preparation of product dossiers, technical files, and responses to information requests required for international market access.
- Coordinate and complete documents required by federal agencies, maintaining complex files and electronic document management systems, and collaborate with project teams to obtain approval for company products.
- Exercise influence at the middle management level, executing tasks and making decisions in alignment with our global regulatory strategy.
- Serve as the primary interface with affiliates to coordinate and complete international regulatory documents and samples for product registration and marketing.
- Act as the primary point of contact with federal governmental agencies, embassies, and consulates in Germany, as well as the center of excellence for requests related to all products with manufacturing licenses or released within the EU marketplace.
- 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 manufactured in Germany.
- Work directly with third-party manufacturing companies to obtain documents.
- Bachelor's degree in life science, clinical research studies, or engineering.
- Previous regulatory experience is preferred.
- Several years of experience in a regulated business environment (e.g., legal office, regulated industry).
- Good knowledge of the English language.
- Developed negotiation skills for interactions with governmental agencies.
- Ability to organize data and identify issues or gaps in documentation, and effectively communicate in oral and written forms.
- Experience with Microsoft Office suite, particularly Excel, Word, Outlook, and Teams.
- Working knowledge of database management.
- Experience with Microsoft SharePoint tools and ability to navigate and update documents within SharePoint sites.
- Continued knowledge of current policies and practices issued by local German federal agencies for completion of document requests and legalization requirements.
- Maintain active awareness of regulatory policies/procedures to learn and better understand how the landscape of regulations changes over time.
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Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland GULP – experts united VollzeitUnlock Your Career in Regulatory AffairsWe are seeking a highly skilled Regulatory Affairs Manager to join our team at GULP – experts united. As a key member of our regulatory team, you will play a crucial role in ensuring the compliance of our products with international regulatory requirements.About the RoleProvide support to complete product dossiers,...
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