Regulatory Affairs Associate (on-site Marburg)

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel is seeking a detail-oriented and organized Regulatory Affairs Associate to 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