Senior Regulatory Affairs Expert

1 dzień temu

Warszawa, Mazovia, Polska Parexel Pełny etat

Parexel is a leading Clinical Research Organization (CRO) that seeks a highly qualified Principal Regulatory Affairs Consultant with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule.

The ideal candidate will possess strong regulatory affairs experience, project management skills, and in-depth knowledge of post-approval CMC activities.

This role can be home or office based in various European locations.

Key Responsibilities:

  • 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.
  • Develop and implement submission strategies and plans for post-approval CMC activities, including 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.
  • Coordinate submission preparation with various departments, including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.
  • Write and review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
  • 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.

Experience and Skills Required:

  • University-level education in Life Sciences or equivalent by experience.
  • Extensive experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.
  • Strong understanding of CMC and post-approval regulatory requirements.
  • Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations.
  • Knowledge of small molecule 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).

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