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Regulatory Affairs Associate (on-site Marburg)
Primary Location: Germany, Remote Job ID R0000041667 Category Regulatory Affairs Date Posted 05/18/2026Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
Parexel is seeking a detail-oriented and organizedRegulatory Affairs Associateto join our growing team. This position serves as the main operational contact for internal regulatory colleagues and Subject Matter Experts (SMEs), providing essential support for the coordination of in-house legal and administrative documentation to customize local regulatory maintenance activities.
As a Regulatory Affairs Associate, you will be responsible for managing a diverse portfolio of regulatory documentation, vendor relationships, and administrative tasks that are essential to maintaining our regulatory standing with global health authorities. This role requires exceptional attention to detail, strong organizational skills, and the ability to manage multiple priorities in a fast-paced environment. You will play a critical role in ensuring seamless regulatory compliance and documentation management across multiple jurisdictions, with a particular focus on supporting our client's Marburg site operations.
This is a full time and fully office based role in Marburg.
Role Responsibilities:
Ordering and Management of Regulatory Certificates - Order Certificates of Pharmaceutical Products (CPPs) from regulatory authorities including Swissmedic, EMA, TGA, and others and maintain organized repositories of CPP documentation
Quality Assurance Documentation - Order GMP certificates and other QA documents, organize and maintain comprehensive documentation repositories, provide administrative support for CMC documents including QP sign-off, stamping, and scanning
Paralegal and Translation Services - Coordinate ordering of legalisations, apostillations, and other paralegal document requests, manage translations and vendor administration, maintain vendor relationships and performance standards
Registration and Sampling Coordination - coordinate registration samples relevant to the business unit, ensure timely availability and proper documentation of samples
Regulatory Compliance and Fees - execute variation and annual fees payments to regulatory authorities, ensure timely submission of required documentation
Intelligence and Reporting - capture record-related intelligence and requirements linked to Regulatory Strategy and Operations (RSO) activities, provide accurate reporting to support regulatory decision-making
Document Management and Archiving: provide on-site support for paper-based certificate legalization; manage local authority correspondence and approval letters; oversee end-to-end coordination with Rhenus physical archiving to ensure inspection readiness; administratively manage handling of site-specific incoming paper post for entire local team staff; scan, archive, and ship approval letters as required; maintain organized filing systems for inspection readiness
Skills and Experience required for the role:
Bachelor's degree or in a ccientific discipline
Knowledge of current international pharmaceutical regulations
Familiarity with GMP and quality assurance processes
Experience coordinating with multiple regulatory authorities
Iinitial years of experience in a regulatory affairs, pharmaceutical, or biotech industry environment
Knowledgeable on legal frameworks governing pharmaceutical products
Demonstrated experience managing regulatory documentation and vendor relationships
Excellent interpersonal and communication skills (both written and verbal)
Proficiency in local language with extensive working knowledge of English
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