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Senior Regulatory Compliance Officer

1 week ago

Manila, National Capital Region, Philippines Manpower Philippines Full time

Regulatory Compliance Role

As a Senior Regulatory Compliance Officer, you will play a key role in ensuring that our pharmaceutical products comply with relevant laws and regulations. You will work closely with cross-functional teams to ensure that our products meet regulatory requirements.

Key Responsibilities:

  • Develop and implement regulatory strategies to ensure compliance with laws and regulations.
  • Review and analyze 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.
  • 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.
  • Strong analytical and problem-solving skills.
  • Excellent communication skills.