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Regulatory Affairs Manager

₱ 79,998.00 monthly ·  Parañaque, National Capital Region ·  8 May (updated)

HR SPECTACLES

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  • Description



  • Roles and Responsibilities:

    – Responsible for managing all matters concerning the Regulatory Department pertaining to Drugs, Medical Devices, Food, Cosmetics.

    - Experience working with vaccines

    Knowledge and experience with Philippines FDA procedures, regulations and procedure.

    – Monitor and check submissions of License to Operate, CPRs and other related regulatory correspondence with FDA.

    – Develop and maintain a schedule of periodic updates for all regulatory submissions, follow ups etc.

    – Ensure that all FDA licenses, certificates and permits are updated and valid.

    – Proficiency in creating/reviewing packaging layouts in line with existing standards set by FDA.

    – Update related departments on latest regulatory requirements.

    – Perform other related duties as required by FDA, other Government Agencies and other tasks assigned as needed.

    – Organize and maintain the regulatory filing system.

    Qualifications:

    – Bachelor’s Degree in Pharmacy/Pharmacology with valid PRC License.

    – 3 to 5 years of working experience in the related field is required for this position.

    – Knowledgeable with Food and Drug Administration (FDA) regulatory compliances.

    – Excellent level in verbal and written communication skills.

    – Knowledge in Graphic Designing will be an advantage.

    – Organized and attentive to details.

    – Demonstrate pro-active approaches to problem-solving with strong decision-making capability.

    – Good interpersonal skills.

    – Computer proficient and capable in Microsoft Office, Google Suite, etc.

  • Requirements

  • Minimum education level: Bachelor´s Degree
  • Years of experience: 5
  • Availability for travel: No
  • Availability for change of residence: No
  • OFERTA_DISCAPACIDAD OFERTA_DISCAPACIDAD_YES

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Job summary

  • Regulatory Affairs Manager

  • Parañaque, National Capital Region

  • Company

    HR SPECTACLES
  • Type of contract

    Permanent contract

  • Work type

    Full Time

  • Salary

    ₱ 79,998.00 monthly

  • Apply