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Regulatory Affairs Specialist Lead

2 weeks ago


Manila, National Capital Region, Philippines Manpower Philippines Full time

Job Overview

Manpower Philippines is seeking a highly skilled Regulatory Affairs Specialist Lead to join our team. This role will be responsible for ensuring compliance with pharmaceutical product registration, variation, line extension and other related laws and regulations.

Key Responsibilities:

  • Monitor and disseminate information on changes related to the Regulatory Authority: laws and regulations affecting registration, manufacture, distribution, and sale and marketing of products.
  • Facilitate communication between Area Regulatory lead, local distributor, and the local regulatory authority.
  • Develop registration strategies, prioritize assignments; implement regulatory plan and coordinate multiple projects and activities in accordance with strategic company objectives, annual plan and targets.
  • Review, analyze and coordinate data for new products, renewal and variation submissions, and line extensions according to priorities and responses to deficiency letters.
  • Maintain an awareness of country's regulatory legislation and assess its impact on AbbVie's business.
  • Manage labeling changes, artwork development and artwork approval of packaging material components.
  • Update and maintain regulatory databases.

Requirements:

  • 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.
  • Understands business needs and impact of regulatory issues.
  • Strong interpersonal skills.
  • Strong communication skills – both oral and written.