Senior Regulatory Affairs Specialist
hace 2 semanas
Unlock Your Expertise in Regulatory Affairs with Parexel
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. As a recognized professional in your field of expertise, you will leverage your technical skills and knowledge to deliver exceptional consulting services to our clients.
Key Responsibilities:
- Provide project leadership, ensuring 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.
- Assess change controls and provide regulatory assessments of quality changes in production and quality control.
- Review study reports from 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 and author articles for industry publications.
- Identify and mitigate risks associated with regulatory procedures.
- Mentor and coach junior team members.
- Collaborate with Account Management to prospect 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 CMC and quality.
- Strong understanding of CMC and post-approval regulatory requirements.
- Experience in writing CMC sections of regulatory documents.
- Knowledge of small molecule processes.
- Proficient account planning and support abilities.
- Networking skills.
- Team spirit, flexibility, accountability, and organizational skills.
- Strong project leadership and management knowledge.
- Business acumen for analysis and decision-making.
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