Regulatory Affairs Expert
hace 1 semana
At Parexel, we're committed to delivering exceptional consulting services to our clients. We're seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for biological products and/or vaccines.
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, 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.
- 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 vaccines or biological 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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