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Pharmaceutical Regulatory Affairs Leader
1 month ago
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.
