Description

Overall Purpose of The Job:

• Lead the local regulatory affairs team in:
• The effective registration of all new products and line extensions for Philippines according to business launch plan
• Ensuring that registration licenses are up-to-date throughout the lifecycle of products as required by local regulations and as data emerges, where applicable
• Reclassification strategies and the application of existing products to allow for effective expansion of distribution channels/support commercial strategies
• Update safety information of product labeling for Company Core Data Sheet (CCDS) and (Core Patient Package Insert (CPPI) as planned
• Ensure the team’s compliance for promotional materials
• Ensure timely implementation of artworks of package inserts and packaging components
• Comply with local regulations and requirements, e.g., submit reports to Health Authorities (HA) according to all prevailing regulations and internal requirements.
• Own and lead effective implementation of our external engagement strategies, and lead on key regulatory agenda on key industry trade associations, e.g., PHAP, PAPP
• Establish and maintain a good relationship with internal, e.g., inter- and intra-department at local/regional/global level, and external stakeholders, e.g., HA, third party suppliers
• Ensure all outgoing messages have complied with local regulations and company requirements
• Assess and communicate new local laws impacting business to all relevant stakeholders
• Other jobs as assigned by the supervisor
  
  

Essential Duties and Responsibilities:

• Ensure the compliance with local regulations/requirements and standard internal procedures
• Ensure the smooth registration process to gain approval as planned
• Ensure the product package inserts do not deviate from the international package inserts or otherwise follow the management of local labeling deviation
• Ensure the promotional materials will conform to the approved product package inserts, corporate policy, and PHAP and PAPPI code of ethics and get approval from HA as planned
• Ensure the supply can continue with variations approved and implemented on time or otherwise inform the supply and marketing team for the back-up plan
• Where applicable, serve as the company pharmacist and relevant drug product license holder
• Support SEA regional projects when opportunities arise

Qualifications

• Bachelor’s degree in Pharmaceutical Sciences with good command of English
• Minimum ten year-experience in area of Regulatory Affairs responsible for pharmaceutical products; Experience in Quality Assurance will be an advantage
• Computer literacy-skill to use business applications
• Ability to effectively handle and manage all regulatory activities throughout the lifecycle of pharmaceutical products and provide sufficient support to other departments
• Ability to work on multiple tasks and under pressure
• Sound performer in interacting with and influencing regulatory authorities
• Good collaboration with and communication to all relevant stakeholders