Abbott Regulatory & Quality Manager in Singapore, Singapore
Develop registration strategies, prioritizing assignments; implement regulatory plan and coordinate multiple projects and activities in accordance with strategic company objectives, annual plan and Long Range Plan (LRP) targets.
Review, analyse and coordinate data for new product submissions, line extensions according to priorities and responses to deficiency letters. Ensure that the content comply with government regulations priorto submission to Health Department
Monitor the progress of marketing applications and provide management with a monthly registration status in S&OP meeting and NPI.
Implement and manage local quality systems and training programs as necessary to support CAPA, validation, complaint registration, physician sample handling, inspection reporting and tracking, policy implementation, supplier management, document and change control management, distribution and material control.
Ensures implementation of quality metrics at Affiliate level, including adherence to set targets
College or University degree required, technical (life Sciences) or business-related discipline.
Singapore registered Pharmacist
At least 5 years’ experience in Pharmaceutical or medical device (or related industry) GA/Regulatory
Project management and troubleshooting skills
Knowledge of local regulations
Experience in or working with regulatory organizations
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org