Regulatory Affairs Manager (f/m/d)

Regulatory Affairs Manager | Ludwigshafen am Rhein, Germany | Hybrid

This employer is a reputable pharmaceutical company seeking a skilled Regulatory Affairs Manager to join their team. The organization fosters a candid corporate culture and is committed to supporting its employees' growth and development. They are looking for a dedicated professional to play a key role in ensuring product compliance and market access.

The Role

• Coordinate and compile documentation required by federal agencies, managing complex files and electronic document management systems.
• Support the completion of product dossiers, technical files, and responses to information requests.
• Collaborate with project teams to secure approvals for company products.
• Act as the main point of contact for federal governmental agencies, embassies, and consulates in Germany.
• Gather documents from all EU facilities necessary for product registration in relevant countries/regions.
• Liaise with third-party manufacturing companies to obtain required documentation.

What You'll Need

• Bachelor's degree in a life science, clinical research study, or engineering field.
• Several years of experience in a regulated business environment.
• Proficiency with Microsoft Office Suite, including Excel, Word, Outlook, Teams, and SharePoint.
• Working knowledge of database management and electronic document management systems.
• Understanding of current policies and practices issued by local German federal agencies.
• Strong negotiation and communication skills, with the ability to organize data and identify documentation gaps.

What's On Offer

• Competitive salary package based on qualifications and experience.
• Opportunity for permanent employment with the business partner.
• Generous vacation allowance of up to 30 days per year.
• Diverse employee benefits and perks.

Apply via Haystack today!