Pharmaceutical Regulatory Affairs Leader

5 days ago


Uxbridge, United Kingdom Lifelancer Full time

Parexel, a leading Clinical Research Organization (CRO), seeks an expert in Chemistry, Manufacturing, and Controls (CMC) for small molecule regulatory affairs. As a Principal Regulatory Affairs Consultant, you will lead post-approval CMC activities, providing strong project management skills and regulatory knowledge.

This role offers flexibility with home or office work arrangements in various European locations.

Key Responsibilities:

  • Project Leadership: Ensure successful planning and setup of projects, providing overall leadership.
  • Client Relationship Management: Maintain accurate project reporting and deliver results that meet client expectations.
  • Submission Strategies: Develop and implement submission plans for post-approval CMC activities, including variations, renewals, market expansions, and annual reports.
  • Regulatory Assessments: Evaluate change controls and provide quality assessments of production and quality control changes.
  • Study Report Review: Ensure compliance with regulatory requirements by reviewing study reports from quality control and production departments.
  • Interdepartmental Coordination: Coordinate submission preparation with manufacturing, supply chain, quality control, quality assurance, and other regulatory departments.
  • Submission Content Writing: Write and review submission content to ensure alignment with regulatory requirements, particularly for variations and health authority inquiries.
  • Team Collaboration: Deliver project requirements within a team environment, prioritizing workload for yourself and the project team.
  • Presentation and Communication: Engage audiences through seminars and industry meetings, author articles for publications, and demonstrate expertise and Parexel's capabilities.
  • Risk Identification and Mitigation: Identify, escalate, and mitigate risks associated with regulatory procedures and activities.
  • Mentorship: Mentor and coach junior team members.
  • New Business Opportunities: Collaborate with Account Management to identify and leverage new business opportunities.

Required Skills and Qualifications:

  • Education: University-level education in Life Sciences or equivalent experience.
  • Regulatory Affairs Experience: Extensive experience in regulatory affairs, particularly in technical/CMC/quality areas within the pharmaceutical industry.
  • CMC Knowledge: Strong understanding of CMC and post-approval regulatory requirements.
  • Writing Experience: Experience in writing CMC sections of regulatory documents, such as registration files or variations.
  • Small Molecule Processes: Knowledge of small molecule processes.
  • Account Planning: Proficient account planning and support abilities.
  • Negotiation and Communication: Networking skills for expanding professional connections.
  • Soft Skills: Team spirit, flexibility, accountability, organizational skills, and self-confidence.
  • Business Acumen: Strong project leadership and management knowledge, business acumen for analysis and decision-making.
  • Technical Skills: Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.
  • Languages: Fluent in English (written and spoken).

Estimated Salary Range: £80,000 - £120,000 per annum, depending on location and experience.



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