Regulatory Affairs Assistant [Chemist] - BGC

Job Descriptions:
  • Assists in ensuring that company products are compliant with registration and licensing requirements of the FDA and IPO
  1. Evaluates, processes, and submits requirements for initial and renewal registration and marketing variations of pharmaceutical products
  2. Processes requirements and coordinates office and warehouse inspection necessary for securing government licenses
  • Develops proposed packaging materials in compliance with regulatory requirements and in conformance with the Standard Export Package Inserts (SEPI)
  • Handles the marketing services requirements of Commercial:
  1. Processes promotional requirements of the Product Management Group for various marketing activities
  2. Processes and furnishes bidding, hospital formulary, and seeding trial requirements with Commercial
  • To recognize reportable Adverse Event (AE) or safety information and ensuring the necessary information is forwarded to the Local Pharmacovigilance Responsible Person (LPVR) in Merck, Inc. Philippines within 24 hours
  • On handling customer complaint, the employee must obtain and compile the information regarding a received complaint and to transfer the information to the local complaint manager (Quality Assurance Manager)
  • Performs other functions that may be assigned / required from time to time

Qualification:

  • Candidate must possess at least a Bachelor's/College Degree, Professional License (Passed Board/Bar/Professional License Exam), Chemistry or equivalent.
  • At least 1 year(s) of working experience in the related field is required for this position.
  • Amenable to work in BGC, Taguig
  • Willing to start ASAP

Interested applicants may send their updated CV to ldbarrete@knollridges.com.ph

Subject: [Applicant's Name] - [Position]