Senior Regulatory Affairs Specialist

hace 5 días


Alcobendas, Madrid, España Parexel A tiempo completo

At Parexel, we're driven by a shared purpose: to help our clients achieve their goals and improve patient outcomes. As a Senior Regulatory Affairs Specialist - CMC Expert, you'll be part of a dynamic team that's passionate about delivering exceptional results.

About the Role

We're seeking an experienced professional with expertise in Chemistry, Manufacturing, and Controls (CMC) for biological products and/or vaccines. You'll work closely with our clients to develop and implement submission strategies and plans for pre- and post-approval CMC activities, including MAA/BLAs variations, renewals, market expansions, and annual reports.

  • Develop and implement submission strategies and plans for pre- and post-approval CMC activities, including MAA/BLAs variations, renewals, market expansions, and annual reports.
  • Assess change controls and provide regulatory assessments of quality changes in production and quality control.
  • Review study reports from the quality control and production departments to ensure compliance with regulatory requirements, with ability to incorporate such report data into Module 2.3/3.
  • Coordinate CMC submission preparation with various departments, including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and CMOs.
  • Write and review CMC submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
  • Serve as a Project Leader, providing overall project leadership and ensuring the project's successful planning and set-up.
  • Act as the main client contact, maintaining accurate project reporting and delivering to meet client expectations.
  • Collaborate within a team environment to deliver project requirements. Prioritize workloads, both for yourself and the project team, to achieve project scope and objectives.
  • Deliver engaging presentations at seminars and industry group meetings. Author articles for industry publications, demonstrating expertise and showcasing Parexel's capabilities.
  • Identify, escalate, and mitigate risks associated with regulatory procedures and activities.
  • Mentor and coach more junior members of the team.
  • Collaborate with Account Management to prospect and leverage new business opportunities.
  • Effectively communicate Parexel's service offerings, demonstrating our capability to support client needs.
About You

To succeed in this role, you'll need:

  • A university-level education in Life Sciences or equivalent by experience.
  • Extensive experience in regulatory affairs, specifically particularly related to technical/CMC/quality, within the pharmaceutical industry.
  • A strong understanding of CMC and post-approval regulatory requirements.
  • Experience in writing and SME reviewing CMC (technical) sections of regulatory documents such as registration files or variations.
  • Knowledge of vaccines or biological processes.
  • Proficient account planning and support abilities.
  • Networking skills to expand professional connections.
  • Team spirit, flexibility, accountability, and organizational skills.
  • Strong project leadership and management knowledge.
  • Strong business acumen for analysis and decision-making.
  • Self-confidence and control in professional engagements.
  • Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.
  • Fluent in English (written and spoken).
What We Offer

We're proud to offer a competitive salary, ranging from €80,000 to €120,000 per annum, depending on experience. Additionally, you'll enjoy:

  • A comprehensive benefits package, including health insurance, pension plan, and paid time off.
  • The opportunity to work with a leading Clinical Research Organization (CRO) and contribute to groundbreaking projects.
  • Professional development and training opportunities to enhance your skills and expertise.
  • A collaborative and dynamic work environment with a diverse team of professionals.
  • Flexible working arrangements, including home or office based options in various European locations.


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