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
