Regulatory Manager

7 hours ago

Makati City, National Capital Region, Philippines MEDCHOICE PHARMA, INC Full time ₱600,000 - ₱800,000 per year

About the role

As the Regulatory Manager at MedChoice Pharma, Inc., you will play a pivotal role in ensuring the company's compliance with the complex regulatory requirements of the pharmaceutical industry.

QUALIFICATIONS:

  • Graduated with a Bachelor's Degree in Pharmacy
  • Progressive experience in Regulatory Affairs within the Philippine pharmaceutical, medical device, or healthcare industry.
  • At least 2 years in a managerial or supervisory role managing regulatory submissions and teams.
  • Deep, practical knowledge of FDA Philippines administrative orders (A.O.s), circulars, and guidelines related to product registration and post-market compliance.
  • Managing end-to-end alignment and coordination with multiple stakeholders to ensure the timely launch of new products.

SKILLS NEEDED:

  • Strategic & Critical Thinking: Ability to analyze complex regulatory requirements and develop efficient approval protocols to ensure compliance.
  • Exceptional Communication & Negotiation: Highly skilled in written and verbal communication, capable of building positive relationships with regulatory authorities, internal, and external stakeholders.
  • Attention to Detail: Meticulous approach to document management, artwork reviews, and marketing material reviews.
  • Project Management: Demonstrated ability to manage multiple complex projects simultaneously under strict deadlines.
  • Expert Knowledge of Local Regulations
  • Preferably with Importation/Exportation experience, especially in the ASEAN market.

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