Regulatory Affairs Assistant

2 weeks ago

Pasig, National Capital Region, Philippines Hovid Full time

Pharmaceuticals & Medical Devices (Healthcare & Medical)

  • Must be a graduate of BS Pharmacy; License is not required but an advantage
  • Male or Female
  • With at least 6 months to one year regulatory affairs experience in a pharmaceutical company; fresh graduates are also welcome as long as trainable
  • Willing to work in Shaw Blvd., Pasig City
  • Trainable and willing to do fieldwork (visits to FDA and inspection during shipments)

JOB RESPONSIBILITIES:

Regulatory:

  • Prepares technical documentary requirements of every renewal of product in accordance with FDA checklist such as CPRs, letters of appeal/s, letters of variations, batch notifications, letters to expedite, and others as needed and submits to FDA six (6) months prior to expiry of the registration.
  • Prepare and proofread artwork of packaging materials of products subject for registration in accordance with FDA labeling requirements/guidelines. Works hand in hand with Regulatory Affairs Officer for timely submission to head office and gives timely feedback.
  • Processes requests for payment for renewal of products to accounting. Must be submitted 2-3 days prior to submission to FDA.
  • Maintain and manage records (database) of certificate of product registration for all renewed products being distributed by Hovid Inc. (Drugs, Food, Cosmetics, HUHS.)
  • Follows up pending registration applications to FDA / PSD section for both new and existing products. Visits FDA personally as needed. Obtain registration approval for products under renewal and variation within the year.
  • Attend FDA seminar in all matters pertaining to product registration and operation of pharmaceutical company
  • Keep and update records of FDA policies and guidelines
  • Prepare online application forms of products for renewal.
  • Proofread brochure artwork of products prepared by Marketing Department.
  • In the absence of Regulatory Affairs Officer, reviews dossier for initial registration according to FDA guidelines.
  • Assist Logistics Supervisor in inspection of shipment as the need arises with emphasis on checking the registration number and shelf life.
  • Assist logistics team and auditors during annual inventory in distributor and partner warehouses

Biddings:

Issuance of regulatory and price documents to distributor for bidding participation This includes CPRs, CGMP Clearance, inserts, brochures, BE Studies, Manufacturer's Authorizations, and others as may be required on top pf the bid price. This includes coordination and seeking price approvals to concerned signatories and approvers.

Your application will include the following questions:

How many years' experience do you have as a Regulatory Affairs Assistant?

How much notice are you required to give your current employer?

Are you willing to undergo a pre-employment background check?

Hovid (formerly known as Ho Yan Hor) carries with her years of invaluable experience in the pharmaceutical industry. Began in 1945 in Ipoh, Malaysia, Hovid is today one of the leading pharmaceutical manufacturers of high quality and innovative medicinal preparations and health supplements with more than 400 products distributed to over 50 countries globally.

Listed on the Main Board of Kuala Lumpur Stock Exchange, Hovid spells familiarity and quality among healthcare providers. With the various divisions in the organization that have been established through years of experience, we are able to deliver speed, excellence and above all, Continuous Innovation and Quality.

Hovid Inc. in the Philippines is a subsidiary office of Hovid. The Philippines office is engaged in providing and distribution of the high quality pharmaceutical and consumer products of Hovid to the public of the Philippines.

Hovid (formerly known as Ho Yan Hor) carries with her years of invaluable experience in the pharmaceutical industry. Began in 1945 in Ipoh, Malaysia, Hovid is today one of the leading pharmaceutical manufacturers of high quality and innovative medicinal preparations and health supplements with more than 400 products distributed to over 50 countries globally.

Listed on the Main Board of Kuala Lumpur Stock Exchange, Hovid spells familiarity and quality among healthcare providers. With the various divisions in the organization that have been established through years of experience, we are able to deliver speed, excellence and above all, Continuous Innovation and Quality.

Hovid Inc. in the Philippines is a subsidiary office of Hovid. The Philippines office is engaged in providing and distribution of the high quality pharmaceutical and consumer products of Hovid to the public of the Philippines.

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Perks and benefits

Medical

Miscellaneous allowance

Loans

Parking

monthly and quarterly incentives on top of salarie

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