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(Senior) Regulatory Affairs Associate - Labelling & Artwork

, Poland Date posted 04/10/2025 Job ID R0000031247

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.

In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.

Success Profile

Check out the top traits we're looking for and see if you have the right mix.

  • Detail-Oriented
  • Proactive
  • Problem-Solver
  • Results-Driven
  • Organized
  • Multi-Tasker
  • "When submitting major market applications, it’s key to ensure that the technical integrity of all data meets regulated requirement standards. Parexel makes this possible with a diverse team of seasoned professionals who care about getting important medicines to patients. This is Regulatory Operations at its best."

    Chris – Associate Director, Regulatory & Access
  • "In this role, I have had the unique opportunity to work with regulatory experts who are not only some of the most distinguished in their field, but are also some of the most compassionate people I know. I’ve been able to grow so much professionally by standing on the shoulders of giants!"

    Riley – Regulatory Affairs Consultant

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Management

    Strong management with depth of experience working for global health authorities.

Responsibilities

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


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