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Regulatory Affairs Consultant - CMC small molecule

Erek Daily Alerts - PAREXEL, Leeds

Regulatory Affairs Consultant - CMC small molecule

Salary not available. View on company website.

Erek Daily Alerts - PAREXEL, Leeds

  • Full time
  • Permanent
  • Onsite working

Posted today, 24 Nov | Get your application in now to be one of the first to apply.

Closing date: Closing date not specified

job Ref: 060e2b703d7e4db986f7d8f7b551ccf6

Full Job Description

  • 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.

    Parexel, a leading Clinical Research Organization (CRO), is seeking a highly qualifiedPrincipal 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. As a recognized professional in your field of expertise, you will utilize your rainmaking skills and extensive knowledge of our consulting models and methodologies to deliver exceptional consulting services to our clients. This is a unique opportunity to showcase your technical skills, specialist knowledge, and mentorship abilities., 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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