Head of Regulatory Affairs, Philippines

Johnson & Johnson



Manila, Philippines


Position summary

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

Why you should apply for a job to Johnson & Johnson:

  • Ranked as one of the Best Companies for Women in 2020

  • 4.2/5 in overall job satisfaction

  • 4.2/5 in supportive management

  • 71% say women are treated fairly and equally to men

  • 88% would recommend this company to other women

  • 84% say the CEO supports gender diversity

  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).

  • Global exercise reimbursement.

  • Two weeks off (one of them fully paid) for volunteer work.