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Regulatory Affairs Manager

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Regulatory Affairs Manager

  • Location:

    Philippines

  • Sector:

    Monroe Health

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Jeleica Uy

  • Contact email:

    Jeleica@monroeconsulting.com.ph

  • Job ref:

    BBBH410523_1672811771

  • Published:

    24 days ago

  • Expiry date:

    2023-02-03

  • Client:

    Monroe Consulting Group

Executive Search Firm Monroe Consulting Group Philippines is recruiting on behalf of a multinational Pharmaceutical company. Our respected client is seeking a Regulatory Affairs Manager experience in filing dossiers with FDA registration. S/he will act as the Liaison Officer to FDA Philippines. The job is based in BGC, Taguig City, Philippines.

Key job responsibilities include:
  • Acts as the Liaison Officer to FDA Philippines.
  • Timely secure necessary permits - LTO, Foreign GMP Clearance from FDA & other business permits
  • Coordinate closely with department concerned towards compliance of documents required for FDA application/ registration as per ACTD guidelines.
  • Ensure compliance with regulation set by the FDA in terms of Timely submission of Drug Product Dossier (Initial/Renewal), Variation, baby CPR, Bio waivers, Query responses and seek early approval to keep product ready for commercial launch .
  • Life Cycle Management of CPR, LTO, GMP and other Business certificates.
  • Perform other task as may be assigned.
  • Provide daily & weekly activity updates.



Key job qualifications:

  • Bachelor's Degree
  • Registered Pharmacist
  • 3-5 years' experience in a pharmaceutical industry handling drug products
  • PRC license should be free to apply LTO
  • Team player, strategic thinker and good analytical skills
  • Good interpersonal and communication skills
  • Must be willing to report onsite daily