Regulatory Affairs Specialist

Background

Ensuring compliance of establishment / procedures / products to regulatory and pharmacovigilance requirements of FDA 

Accountability

Updated regulatory requirements (Licenses, Certificates of Product Registration, permits) and availability of such requirements to enable marketing of products; ensuring pharmacovigilance system

INITIAL PRODUCT REGISTRATION   •    Review and preparation of dossier, facilitation of submission to FDA, compliance of deficient requirements, monitoring and follow-up of status with FDA and securing approval 

RENEWAL OF PRODUCT REGISTRATION OF EXISTING PRODUCTS •  Review and preparation of dossier, facilitation of submission to FDA, compliance of deficient requirements, monitoring and follow-up of status with FDA and securing approval

VARIATION APPLICATIONS FOR EXISTING PRODUCTS •    Review and preparation of dossier, facilitation of submission to FDA, compliance of deficient requirements, monitoring and follow-up of status with FDA and securing approval

MAINTENANCE OF PHARMACOVIGILANCE SYSTEM •  Conduct of PV activities as per schedule/frequency stated in PV /SDEA agreements with principals and as per PFDA guidelines 

REGULATORY AND PRODUCTS MonITORING •  Prepare and collect documents required for hospital/formulary inclusions of products and bidding requirements•  Coordinate with internal and external customers with regards to regulatory requirement 

Must-have Qualificationa.    Academic requirements – Bachelor’s degree in Pharmacy, Licensed Pharmacist b.    Experience – Minimum of 1 - 2 years of work experience in the pharmaceutical industry preferably with background in regulatory affairs. c.    Language proficiency – proficiency in written and oral Englishd.    Technical Skills – Computer proficiencye.    Traits - Interpersonal and management skills; Good communication and negotiation skills; Good working knowledge of regulation of pharmaceuticals (background in ASEAN guidelines in the registration of pharmaceuticals) and pharmacovigilance

Nice-to-have Qualification•          Attendance to Qualified Personnel in Regulatory Affairs (QPIRA) Training for Pharmaceuticals and FDA Training on Licensing of Drug Establishments; •          Attendance to Pharmacovigilance/Good Vigilance Practice (GVP) trainingWhich departments do the department often contact and coordinate in order to achieve their goals?1)   Regulatory Affairs Department of Headquarters- registration requirements, regulatory issues2)   Foreign Principals- registration requirements, approval of product labeling materials prior to manufacture of the product, pharmacovigilance requirements (PSUR/ADE reports), product complaints, request for medical or scientific information3)   Marketing department - approval and monitoring of promo materials/compliance with regulations on ethical marketing practices/medical information inquiries4)   Sales department - pharmacovigilance reporting, product complaints, medical information/technical inquiries on products and requests for documentary requirements for bidding purposes and hospital formulary inclusion applications