Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Responsibilities include, but are not limited to:
• Support the creation, development, maintenance and implementation of the long-term strategic approach for Global Regulatory Compliance and Training, identifying key performance indicators, areas for improvement and ensuring compliance with current regulatory policy, legislation and guidance. Identify and, if appropriate, anticipate changes to regulatory policy, legislation and guidance
• Leads the development and implementation of regional strategy for and timely periodic review / update and implementation of appropriate Standard Operating Procedures (SOPs), Working Practices (WPs), and Best Practices (BPs) within Regional Regulatory Affairs.
• Provides guidance and direction to procedure authors (SMEs) to ensure the procedure development process, content and format comply with RA and Corporate requirements
• Partner with other departments interacting with Global & Regional Regulatory Affairs including, but not limited to, Drug Safety Risk Management, Clinical Operations, Corporate Quality and Compliance, Clinical Quality, Medical Affairs to ensure appropriate cross-functional SOPs, WPs, and BPs are in place.
• Liaise with Drug Safety department to ensure the Pharmacovigilance System Master File (PSMF) is updated following related changes in RA SOPs and WPs.
• Provide input into the design and maintenance of a role-based procedure training curriculum. Make curriculum recommendations, analyzes training requirements for new and updated procedures.
• Partners with RA procedure authors / SMEs to provide training to RA personnel on procedures as needed.
• Assesses regional needs for training on non-procedural regulatory topics; designs associated training curriculum; works with SMEs to develop training sessions
• Responsible for managing regional/US RA employee training records for Audit and Inspection readiness.
Audits and Inspections:
Contribute to company strategy for regulatory inspections, where Regulatory Affairs is involved.
• Responsible for preparation for, coordination during and subsequent follow-up activities for GxP audits and inspections related to Regulatory activities in the US, and contributes to follow-up activities for US and global GxP audits and inspections where Regulatory Affairs is involved.
• Contributor for the maintenance of a system for recording and tracking the progress of completion of any agreed Corrective and Preventative Actions (CAPAs) and in particular responsible for ensuring US actions are tracked to completion.
• Review all findings related to Regional Regulatory Affairs activities in internal GxP audit and regulatory inspection reports and ensure CAPAs are implemented as appropriate.
• Bachelor’s degree or equivalent in scientific discipline or life science.
• Minimum of 5 to 7 years of corporate pharma company regulatory affairs compliance and training experience required.
• Significant pharmaceutical industry experience, including experience in a compliance or regulatory affairs role, to include work with either a regional or a global remit.
• Good understanding of the drug development process and the post-marketing environment and also the interdependencies between different departments involved.
• Experience in creating and managing Standard Operating Procedures and understanding of quality management systems.
• Experience in training administration.
• Understanding of GxP Regulatory Inspection processes and requirements.
• Good knowledge of US Regulations.
• Strong facilitation, negotiation and networking skills and a strategic understanding of different functional teams.
• Strong organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
• Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
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Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.