Regulatory Affairs Expert

4 settimane fa

Milano, Lombardia, Italia Parexel A tempo pieno

Unlock Your Potential in Regulatory Affairs

Parexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) 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.

Key Responsibilities:

  • Provide overall project leadership and ensure successful planning and set-up.
  • Maintain accurate project reporting and deliver to meet client expectations.
  • Develop and implement submission strategies and plans for post-approval CMC activities.
  • 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.
  • Write and review submission content to ensure alignment with regulatory requirements.
  • Collaborate within a team environment to deliver project requirements.
  • Deliver engaging presentations at seminars and industry group meetings.
  • Author articles for industry publications.
  • 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:

  • 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.
  • 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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