Compliance Manager, Regulatory Affairs And Pharmacovigilance
Buffalo , NY 14201
Posted 2 weeks ago
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POSITION OBJECTIVE:Develops and documents processes and procedures to ensure compliance with FDA regulations and ICH guidelines concerning INDs and NDAs for Regulatory Affairs and Pharmacovigilance.
Essential Job Functions/Responsibilities
- Implements processes and procedures to ensure compliance with FDA regulations and ICH guidelines concerning INDs and NDAs for Regulatory Affairs and Pharmacovigilance.
- Evaluate quality events, incidents, queries, and complaints to determine root cause and appropriate corrective and preventative actions.
- Develop and implement staff training on departmental processes and procedures.
- Build and maintain a collaborative working relationship with Athenex Corporate Quality Assurance.
- Lead activities associated with the development of new processes and systems to support post marketing activities in regulatory affairs and pharmacovigilance.
- Lead auditing activities to ensure that regulatory affairs and pharmacovilance activities are conducted in accordance with sponsor SOPs, GCP, GPV, industry guidelines, and agency regulations.
- Develop quality metics based on regulatory requirements.
- Ensure readiness for regulatory inspections and provide support during the course of these inspections.
- Communicate any critical compliance risks indentified during routine surveliance activities to senior management.
- Other projects as may be assigned
Required Education & Qualifications
- A minimum of a Bachelors degree in an applicable life-sciences, engineering, or public health field.
- A minimum of 7 years of experience in clinical research, preferably including a least 5 years of experience in clinical compliance/quality assurance
- Experience with electronic Quality Management Systems preferred.
- Excellent verbal and written communication skills.
- Experience with internal auditing, CAPA management, metric development and maintenance.
- Experience in implementing training, supplier management,validation, and complaint programs
Athenex is an equal opportunity employer.We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities.If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.