Regulatory Affairs Consultant Expert

2 dni temu


Warszawa, Mazovia, Polska Parexel Pełny etat

Parexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Regulatory Affairs Consultant with expertise in Chemistry, Manufacturing, and Controls (CMC) for biological products and/or vaccines. As a recognized professional in your field of expertise, you will utilize your skills to deliver exceptional consulting services to our clients.

This role can be home or office based in various European locations. We offer a competitive salary package, estimated at €80,000-€120,000 per year, depending on experience and qualifications.

Job Description

Key Responsibilities:

  • 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.
Experience and Skills Required

We are looking for candidates with a university-level education in Life Sciences or equivalent by experience. The ideal candidate will have extensive experience in regulatory affairs, specifically related to technical/CMC/quality, within the pharmaceutical industry. Strong understanding of CMC and post-approval regulatory requirements is also required. Experience in writing and SME reviewing CMC (technical) sections of regulatory documents such as registration files or variations is an advantage. Knowledge of vaccines or biological processes is desired.

The selected candidate should possess strong project leadership and management knowledge, as well as proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault. Fluent in English (written and spoken) is a must.


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