Johnson & Johnson Careers
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Manager, BioResearch Regulatory Compliance, APAC
Beijing, China; Taipei, Taiwan
Requisition ID: 1700210463W
Manages compliance specialists who interpret federal and local regulations as they apply to products, processes, practices and procedures. Interprets local and global regulations to ensure that products, processes, practices and procedures are in compliance with quality standards. Establishes and updates timelines for delivering components for review. Implements and audits quality assurance procedures to ensure compliance with appropriate statutes and regulations, and that regulatory reporting requirements are met. Ensures delivery of submission packages. Assists with developing and conceptualizing regulatory correspondence. Interacts with regulatory agencies to expedite approvals and resolve regulatory matters. Oversees implementation of policies and procedures to ensure that department operations are in compliance with the appropriate statutes and regulations and that regulatory reporting requirements are met. Reviews and ensures promotional materials and product documentation meet regulatory guidelines. Monitors investigation and approves resolutions to compliance problems, questions, or complaints received from other units of the business, customers, and regulatory agencies.
KNOWLEDGE, EDUCATION, EXPERIENCE, COMMUNICATION SKILL REQUIREMENTS:
- Requires at least 5 years of experience with 3 plus years experience and demonstrated leadership in a quality function working on complex and significant compliance topics. Must have comprehensive knowledge of worldwide GCP, GLP, PV, and IT compliance regulations and guidelines. Requires knowledge of latest auditing, investigation and remediation techniques as well as leadership experience with inspections.
- Demonstrated effective influencing, interpersonal, written and verbal communications skills as well as a proven track record of sustaining compliance in complex organizations. Regulatory Authority experience is desirable.
- BS required. Masters in related field, advanced degree desirable.
Johnson & Johnson Pte. Ltd. (8435)