Regulatory Affairs Specialist
4 weeks ago
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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