Regulatory Affairs Specialist

3 weeks ago

Taguig, Philippines Polytechnic University of the Philippines Full time

Description:

We are looking for an experienced Regulatory Affairs specialist with in-depth

knowledge of ASEAN Regulatory requirements in the Registration of pharmaceuticals, medical

devices, food supplements marketing authorization and licenses. Knowledge in implementation

of pharmaco-vigilance will be an advantage. Quality experience in interacting with Center for

Drug Regulation and Research (CDRR), Center for Food Regulation and Research (CFRR) etc.

Duties and Responsibilities:

. You will be in-charge of all regulatory issues and affairs related to the company and

different regulatory bodies with respect to the products assigned under your

responsibility.

. Communicate and coordinate with all manufacturing partners/suppliers with based on

local FDA guidelines on product registrations or other pertinent issues as applicable.

. Coordinate and communicate with the concerned quality control and/or regulatory

officers of manufacturing partners/suppliers to ensure adherence to mutually acceptable

quality standards for the product as required to be complied by FDA Philippines

. Knowledge and skill in review of Product's Technical Dossiers (CTD) and other pertinent

documents and issues related to product registration with FDA Philippines.

. Proficiency in research and analysis for information and issues related to product

specific knowledge if necessary is expected.

. Create and maintain proactively an updated database of all product registrations and

licenses as necessary for renewals and submit the necessary requirements ahead of

time.

. Act as the authorized pharmacovigilance officer for the company by actively coordinating

the issues of product complaints/quality with the end-user and or regulatory authorities,

maintain updated log for submitted product complaints etc.

. Represent the company in various FDA sponsored activities, public hearings and

seminars as necessary.

Qualifications:

. Bachelor's degree in Pharmacy advanced degree may be beneficial.

. Several years of experience in regulatory affairs, preferably in the relevant industry or a

related field.

. Excellent communication and interpersonal skills, with the ability to collaborate

effectively across departments and with external stakeholders.

. Detail-oriented with strong analytical and problem-solving skills.

. Ability to manage multiple projects simultaneously and prioritize tasks effectively.

. Ability to communicate and interact with different agencies and hospital accounts

. Knowledgeable on the process of inclusion and documentation in Philippine Hospitals

Nationwide

Requirements:

  • TOR or Diploma
  • Employment Certificate, if available
  • four copies of 1x1 and 2x2 white background picture
  • Birth Certificate or Passport
  • Valid NBI or Police Clearance
  • Tin Card or Tin Number
  • SSS Card or E1 form
  • Pagibig ID or Pagibig form
  • Philhealth ID or Philhealth form
  • Marriage Certificate if applicable
  • Any two valid ID for opening of China Bank Payroll Account
  • Medical Examination with fit to work to be conducted by our accredited medical clinic

Skills:
(Not indicated)

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