Manager, Regulatory Affairs Process Support, Data Integrity & Compliance

Role Overview

• Provide strategic support and tactical advice to local and regional RA teams in APAC on optimal and compliant application of RA procedures and processes, including implementation of new regulatory requirements, systems and processes
• Facilitate APAC RA input into global/regional processes and procedures impacting APAC RA teams, partnering with assigned Subject Matter Experts (SMEs) as applicable
• Ensure, coordinate, develop and/or deliver (as needed) training and communication on RA processes for APAC, in collaboration with assigned business process owners and SMEs
• Identify and drive prioritized process improvement opportunities in APAC RA.
• Ensure robust tracking of agreed APAC RA data in global tracking systems and tools
• Provide guidance, trainings and communication to APAC RA teams on RA data tracking requirements in global systems
• Coordinate/provide APAC input on global RA data tracking systems, tools, requirements, projects and processes
• Provide support and advice to local and regional RA teams in APAC on efficient and compliant use of RA data systems and tools.
• Ensure the appropriate level of compliance in APAC RA
• Coordinate APAC RA contributions to global audits
• Provide support and coordination to APAC RA teams for LOC audits and inspections, as needed
• Act as the APAC RA contact for Global Regulatory Affairs (GRA) teams and other functions on RA compliance related topics and interpretation of local regulatory requirements
• Support and advise local and regional RA teams in APAC on procedural document related requirements as well as the maintenance, review and applicability of these documents
• Advise local and regional RA teams in APAC on management of non-conformances, CAPAs, quality or compliance issues, as needed.

Requirements

• At least 5 years of relevant experience in pharmaceutical industry and/or Health Authorities
• Excellent understanding of pharmaceutical Marketing Authorisation regulatory procedures and data in APAC countries
• Understanding of regulatory data planning and tracking processes as well as information systems
• Knowledge of RA compliance requirements and advanced process thinking
• Good technical skills and computer proficiency
• Proven ability to monitor multiple actions and timelines and follow up until timely completion
• Ability to work effectively in a matrix organisation with multiple cross-functional stakeholders on global, regional and local level
• Excellent cross-cultural interpersonal skills
• Ability to communicate effectively in English, verbally and in writing
• Flexibility and proactivity
• Team-player

Benefits

• Flexible working arrangements
• Professional development opportunities