(Senior) Regulatory Affairs Associate - Labelling & Artwork

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.

Are you passionate about regulatory affairs and project management in the pharmaceutical industry? Do you have a keen eye for detail and a talent for strategic planning? Parexel is seeking a dynamic Regulatory Affairs Associate to join our Labelling & Artwork team!

This role can be home or office based in various locations - Poland, Romania, Serbia, Czechia, Hungary and Lithuania.

About the Role: As a Regulatory Affairs Associate focusing on Secondary Packaging & Artwork, you will play a crucial role in ensuring our clients' products meet regulatory requirements and market standards. You will be responsible for developing and implementing artwork strategies, managing global product portfolios, and serving as a key liaison between various stakeholders.

Key Responsibilities:

• Develop and oversee secondary packaging and artwork strategies for assigned product portfolios

• Generate and maintain global product portfolio plans, including capacity and budget requirements

• Act as a regulatory expert and ambassador for artwork implementation

• Collaborate with cross-functional teams, including Regulatory Affairs, Supply Chain, and Technical Operations

• Drive continuous improvement in processes and tools related to secondary packaging and artwork

• Ensure compliance with regulatory requirements and internal processes

• Manage change controls, deviations, and investigations related to packaging and artwork

• Provide training and support to staff on artwork strategy and processes

Skills and Qualifications:

• University degree in a Scientific or Technical Discipline

• Few years of experience in a related pharmaceutical industry role

• Strong knowledge of regulatory affairs, particularly in packaging and labeling

• Excellent project management skills

• Proficiency in local language and extensive working knowledge of English

• Outstanding interpersonal and communication skills

• Ability to work effectively in a team environment and independently

• Strong problem-solving and critical thinking skills