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LAN Astute Logistics Inc

Regulatory Officer

1 Year or less Experience

LAN Astute Logistics Inc

With business certificates | Established in 2002 | 11-50 employees
Unit E and G, S.B. Oliveros Bldg., #85 Real St., P. Diego Cera Ave., Las Piñas, Metro Manila
Posted on : December 12, 2019
Job ID : 343966

Details

LAN ASTUTE LOGISTICS INC
 
Is currently looking for:
 
REGULATORY OFFICER
 
Key duties of the job include:
  • Studying scientific and legal documents related to the Food and Drugs Administration (FDA)
  • Gathering, evaluating, organizing, managing and collating information in a variety of formats
  • Ensuring compliance with regulations set by the FDA
  • Preparing documentation and submission of License to Operate (LTO) and Certificate of Product Registration (CPR) applications with the FDA
  • Ensuring that quality standards are met and submissions meet strict deadlines
  • Analyzing complicated information
  • Liaising and negotiating with regulatory authorities
  • Providing advice about regulations to company’s clients
  • Maintaining familiarity with company product ranges
  • Keeping up to date with changes in regulatory legislation and guidelines
  • Writing comprehensible weekly and monthly report to the client and immediate superior respectively
  • Preparing post-transaction documentation such as the determination of total costs, liquidation and gathers necessary   documents to be turned-over to Billing Department
  • Knowledgeable in different computer applications
  • Accountable for any additional tasks or special projects assigned by the immediate supervisor and senior management related to the above-mentioned duties and responsibilities
  • Reports directly to the VP, External Affairs / Licensing Head
Key skills for Regulatory Officers
  • Negotiation skills
  • Analytical skills
  • Time management skills
  • Problem-solving skills
  • IT skills
Requirements and Qualification
  • Graduate of any related courses
  • Preferably knowledgeable in FDA Licensing and Registration application and procedures
  • With good English communication skills
  • Must be highly attentive to details, organized, punctual  and have a good sense of urgency
  • Flexible & willing to work on weekends and comply with extended hours (if necessary)
  • Willing to do fieldwork
  • Can start ASAP
  • Male / Female       


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