APAC Regulatory Affairs Manager - CMC
Singapore Legal
Job description
JOB DESCRIPTION:
Job Responsibilities:
- Write and review CMC dossiers to meet regulatory agency requirement and business needs
- Establish Regional CMC team and working process to support products manufactured at regional sites for the APAC markets
- Provide strategic CMC regulatory advice for assigned products to APAC regional stakeholders
- Develop and manage APAC CMC regulatory strategies ensuring appropriate input is received from all relevant functions
- Provide strategic regulatory guidance to Regional/Affiliate RA
- Liaise with global CMC to leverage their expertise and get advice if necessary
- Prepare regulatory submissions, and develop strategy for response to regulatory agency queries
- Project planning of manufacturing related CMC changes and timelines, providing strategic advice and identifying/recommending improvements
- Monitoring actual vs. planned activities/timelines, identify/recommend improvements to correct or accelerate project progression
- Identify risks and issues impacting project progression, and work out proper remediation plan accordingly
- Oversee the manufacture site related CMC changes and provide strategic advice
- Impart regulatory knowledge and experience to junior staff and relevant stakeholder for specific projects
- Leverage the CMC expertise to manufacturing site and support the necessary training of relevant stakeholders on site
- Manage as individual contributor or assigned team of direct reports
Minimum Education and/or Equivalent Experience and/or Other Experience/Training Required for this Job Role:
- Bachelor's or Higher Degree in Related Scientific Discipline (Biology, Chemistry, Pharmacy, Engineering, Pharmacology, or related subject)
- 8-10 years of experience in Regulatory Affairs, Quality, R&D, Manufacturing, Scientific Affairs or related area, including 3-5 years in Regulatory Affairs
- 3-5 years of working experience in related areas in Asia Pacific countries is required
- CMC writing experience for Innovative Generic, Generic drugs, New drugs is strongly preferred
- Supervisory experience is preferred
- Ability to understand one or more Asian languages is preferred
JOB FAMILY:
Regulatory Operations
DIVISION:
EPD Established Pharma
LOCATION:
Singapore > Singapore : DUO Tower
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 25 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable