Description
Responsibilities:- Initiate, review and approve regulatory changes through the Regulatory Compliance Change Manager (RCCM) system and Product Dossier Manager (PDM) for changes initiated by or impacting COQA managed contractors.
- Provide support for the closure of the deficiency letters and CMC Commitments, Regulatory requests for Renewals, New Product registrations and Post approval variations.
- Serve as the main point of contact for the Global Chemistry, Manufacturing and Controls (GCMC) department or Local Regulatory Affairs in the Offices (for Single market products) for the various regulatory activities involving the COQA managed contractors.
- As the Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) or similar meeting for COQA managed contractors and if needed, participate in Site Quality visits at the contractors.
- Manage routine Customer Quality complaints for commercial Drug Products in PCOM and work in collaboration with the COQA Contractor Quality Lead for ensuring that the investigation reports are appropriate and acceptable.
- Ensure timely closure of complaints and alerting the appropriate colleagues for the confirmed complaints.
- COQA is responsible for the Quality management of approximately 300 contract manufacturers, packagers, and supply partners globally.
- The person will be responsible for regulatory change management activities as a Site Compliance Network Member (SCNM), management of routine complaints and execution of lot disposition activities for the Drug Products and Drug Substances (APIs) manufactured by COQA managed Contractors
Qualifications:
- BA/BS in Science, Engineering, Pharmaceutical Sciences or related technical discipline
- Minimum 5 years of experience in GXP setting (or 3 years with Masters degree)
- Advanced in computer skills such as MS Office applications and good knowledge of enterprise systems such as Trackwise.
- Good command of English language
- Good verbal and written communication skills and able to work in diverse multi-level, cross-divisional and multi-cultural working environment
- Show strong negotiation skills and customer focus
- Demonstrate ability to prioritize work, manage multiple projects act and work independently
- Take initiative and proactive.
- MS Office