Acts to support global compliance commitment management and evaluation of emerging regulations in day-to-day activities. Is responsible for project management of global pharmaceutical regulatory commitments to closure.
Additionally, is responsible for the evaluation of new regulations and changes to existing regulations and communicating the evaluation results to key stake holders and Celgene senior management.
Other responsibilities include participation in compliance projects and initiatives, bench marking compliance and regulatory practices, participation in joint compliance ventures with global partners, and participation in the organization and management of regulatory inspections.
This position works closely with global Celgene departments such as internal auditing functions, regulatory affairs, drug safety/pharmacovigilance, quality, technical operations, legal, and clinical departments.
Regulatory Commitment Monitoring
Supports Global Compliance Commitment Management in the tracking, trending and monitoring of regulatory commitments.
Works closely with corporate and affiliate groups to ensure completion of regulatory inspection commitments including but not limited to compliance auditing, clinical, drug safety, and regulatory affairs.
Administers database related activities, including updating the database with new information or changes to existing entries.
Provides periodic commitment updates to supervisor.
Acts as a consultant to other departments by providing guidance on compliance challenges in support of corporate or affiliate initiated projects.
Compliance Information Management & Bench Marking:
Monitors industry and global regulatory dynamics for changes to existing regulations or emergence of new regulations.
Conducts evaluations of emerging regulations and provides management with an overview of the regulation, changes, and potential impact on business.
Liaises with inter-departmental contacts to ensure that key groups are aware of changes to regulations, for example the training department.
Compliance Project Management:
Acts in a supporting and in appropriate cases a lead role in compliance management projects.
Acts as internal compliance consultant to Celgene customers regarding compliance related issues.
BS or MS in biology, chemistry or related science
Five + years experience in a compliance, quality assurance and/or regulatory related field with thorough knowledge of domestic and international pharmaceutical regulations pertaining to clinical, laboratory, manufacturing and pharmacovigilance
Must be willing to travel up to 25% of the time
Good computer skills and working knowledge of common business software
Excellent organizational, planning, management and leadership skills
Excellent problem-solving, verbal and written communication skills
Must have strong interpersonal and communication skills, and must be able to positively interact with the corporate and affiliate offices
Must be an individual with proven initiative and demonstrated accountability
Professional integrity and maturity are a must