Leading Edge Executive Talent Search Inc.
Leading Edge Executive Talent Search Inc.

Regulatory Affairs Pharmacist  

Leading Edge Executive Talent Search Inc.

  • Makati, Philippines
    22nd Floor, 139 Corporate Center, Valero Street, Salcedo Village, Makati, Metro Manila, Philippines
    Makati
    Metro Manila
    Philippines
    Philippines
  • Full timeFULL_TIME

Expired 6 years ago

2017-12-02T16:00:00+00:00
Job closed.

Job Description

The position is responsible for ensuring compliance with all of the regulations and laws pertaining to Company’s ethical and supplement products. Regulatory Affairs Pharmacists/Officers are the crucial link between the Company, its products and regulatory authorities. Duties and responsibilities are as follows:

Regulatory Affairs

  • Responsible for the Company’s compliance with all of the regulations of BFAD and other related regulatory authorities;
  • Liaises with, and makes presentations to regulatory authorities
  • Develops and writes clear arguments and explanations for new product licenses and license renewals
  • Negotiates with regulatory authorities to ensure marketing authorization for products;
  • Ensures all Certificate of Product Registrations (CPRs) and licenses are renewed on time by proper submission of license requirements and renewals to strict deadlines
  • Properly monitors and sets timelines for license requirements and renewal approvals; keeps an updated CPR data base
  • Keeps abreast of changes in regulatory rules and guidelines that would impact the Company’s products and business operations
  • Attends to FDA audit and ensures compliance to audit findings if there are non-compliances
  • Collates and ensures correctness and completeness of dossier products for initial registration
  • Responsible for initial and renewal registration protocol to FDA and makes necessary follow-ups on the registration status of the product/s
  • Prepares compliance documents to FDA Notice of Deficiencies (NODs) in coordination with the toll manufacturer
  • Implements proper destruction and disposal of expired or rejected and returned goods
  • Conducts periodic audit in toll manufacturer
  • Coordinates with toll manufacturers any developments or changes on regulatory requirements
  • In case of product recall, coordinates with toll manufacturer and FDA during the whole process up to the completion of recall
  • Plans, undertakes and oversees product trials and regulatory inspections
  • Makes recommendations to Management on the disposition of returned products whether for resale or sample, for reprocess or for destruction and disposal
  • Provides strategic recommendations and/or advice to senior management throughout the development of a new product
  • Handles requirements for labelling, storage and packaging

Supply Chain Management and Production

  • Makes recommendation to improve productivity, quality/efficacy of products taking into consideration the market impact and business viability of the products
  • Coordinates preparation of Purchase Orders for approval of CFO and/or President-CEO based on production requirements
  • Coordinates with printers on the development of promotional and packaging materials, including correctness of labels and boxes according to FDA labelling requirements
  • Assigns barcode number to new products and coordinates with GS1 Philippines
  • Updates inventory record of raw and packaging materials as well as finished products
  • Conducts annual physical inventory of all materials stored at the manufacturer’s warehouse, in coordination with Accounting and third party auditor
  • Prepares claims/complaints against courier when there are damages on Finished Goods in transit
  • Evaluates accreditation of suppliers in coordination with the toll manufacturer
  • Coordinates with the manufacture on Purchase Orders (POs) and makes necessary follow ups on the timely delivery of finished goods
  • Prepares quarterly and yearly production forecast based on approved Sales forecast
  • Regularly reviews the production forecast based on actual movement of products
  • Minimizes shortages and keeps the costs down.

Sales Support

  • Researches and prepares product knowledge materials for the training and re-training of Medical Sales Representatives

Other Tasks

  • Other tasks and assignments that may be assigned from time to time

Minimum Qualifications

  • Licensed Pharmacist
  • At least 1-year experience of working in the field of Regulatory Affairs is an advantage
  • Keen to details, highly motivated, flexible, and with a sense of urgency
  • Good written and verbal communication skills
  • Willing to work in Alabang
  • Fresh Graduates are welcome to apply

Jobs Summary

Job Level
Entry Level / Junior, Apprentice
Job Category
Health and Medical
Educational Requirement
Bachelor's degree graduate
Recruiter response to application
Once in a while
Office Address
22nd Floor, 139 Corporate Center, Valero Street, Salcedo Village, Makati, Metro Manila, Philippines
Industry
Human Resources / HR
Vacancy
2 openings
Website
http://leadingexecsearch.com/

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About Leading Edge Executive Talent Search Inc.

Recruitment Process Outsourcing (RPO) Group is a division of Leading Edge Executive Search, Inc. providing RPO and professional staffing services to local & multinational clients from various business sectors. Our team comes with an expertise honed from being experienced staffing professionals and corporate recruiters -- working hard to deliver good matches to our clientele.

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