Head of Regulatory Affairs, Philippines

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, https://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, https://e.g., PHAP, PAPP

• Establish and maintain a good relationship with internal, https://e.g., inter- and intra-department at local/regional/global level, and external stakeholders, https://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