Global Regulatory Affairs Professional

6 days ago


Manila, National Capital Region, Philippines Manpower Philippines Full time

Global Regulatory Affairs Career Opportunity

We are seeking a highly skilled Global Regulatory Affairs Professional to join our team. As a global regulatory affairs professional, you will be responsible for managing the registration process of pharmaceutical products across different countries and regions.

Key Responsibilities:

  • Develop registration strategies, prioritize assignments; implement regulatory plan and coordinate multiple projects and activities in accordance with strategic company objectives, annual plan and targets.
  • Monitor and disseminate information on changes related to the Regulatory Authority: laws and regulations affecting registration, manufacture, distribution, and sale and marketing of products.
  • Review, analyze and coordinate data for new products, renewal and variation submissions, and line extensions according to priorities and responses to deficiency letters.
  • Assess the impact of regulatory issues on business operations.
  • Manage labeling changes, artwork development and artwork approval of packaging material components.

Qualifications:

  • Bachelor's Degree in Pharmacy or Industrial Pharmacy.
  • Minimum of 3 years experience in regulatory function dealing with pharmaceutical products. Experience in new drug and/or new biological drug registration will be an added advantage.
  • Knowledge of Philippines regulations in pharmaceutical.
  • Strong communication and project management skills.

  • regulatory affairs

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