Regulatory Affairs Associate Pharmacist

1 hour ago

Taguig, National Capital Region, Philippines Primover Consultancy Services, Inc. Full time ₱780,000 - ₱1,560,000 per year

JOB QUALIFICATIONS:

  • A registered pharmacist in the Philippines
  • Minimum of 5-7 yrs relevant experience in regulatory affairs within consumer goods, cosmetics or the medical device industry.
  • Proven experience & ability to analyze and interpret regulations effectively
  • Proven track record of successfully developing and executing regulatory strategies and obtaining regulatory approvals for products
  • Experience in interacting with regulatory authorities and managing regulatory inspections and audits.
  • Experience in conducting regulatory intelligence and regulatory monitoring.
  • Experience in developing and maintaining regulatory compliance documentation, including technical files, regulatory dossiers, and other relevant documentation.
  • Experience in conducting regulatory assessments and reviews on product claims, product labels, advertisements.
  • Good communication skills, both written and verbal, to effectively interact with stakeholders and teams.
  • Ability to work independently and lead regulatory compliance in Philippines.
  • Ability to managing and executing regulatory projects in a timely manner.

JOB RESPONSIBILITIES

  • Be the Qualified Person with the require Pharmacist License needed to maintain all KCPI LTOs.
  • Liaison officer between the company and relevant government regulatory agencies including being present during audits by FDA.
  • Provide Regulatory assessment and advice to stakeholders.
  • Prepare, evaluate, and file product registration documents (initial, renewal, amendment, exemption, and compliance) to be submitted to FDA and DOH. To ensure that all PIF documents are in place.
  • Responsible for the timely submission of new and renewal of registered products, permits and licenses.
  • Responsible for product claim & product label approval, ensure all product claims & product labels go through the approval process in KC system.
  • Notify FDA in case of changes made in the status of business such as change in ownership, change of supplier, change of pharmacist, and change of business address.
  • To provide a contingency plan or procedure for a systematic, effective, and prompt recall in case a product is found violative and ordered recall from the market.
  • Maintain a good file of original documents such as company licenses, certificates of product registration, and certificates from factories and diplomatic officials
  • Monitor regulations change that impacts KC PI, conduct risk assessment and business impact & perform communication with stakeholders on the impact.
  • To monitor the development of new regulations, guidelines, standards that are relevant to KC products. Work with Manager/Regional Regulatory to provide feedback to authorities on draft documents.
  • To provide timely update and advise KC on potential impact of new regulations, guidelines, standards.
  • To secure promo permits from FDA and other regulatory bodies.
  • To conduct Good Distribution Practice (GDP) training when needed and advise warehouse personnel on FDA GDP/storage requirements.
  • Submit reports to Manager/Regional Regulatory as required.
  • Direct involvement in all KCPI projects (all sectors) to provide regulatory support
  • To deploy Global Regulatory Affairs, GRA policies and processes in KCPI.
  • To conduct Agency Reporting with government bodies according to GRA standard & procedure.
  • To represent KCPI in trade associations meeting.
  • To build network with FDA officers.
  • To provide training to stakeholders on product Regulatory Requirements and other trainings as required

Job Type: Fixed term

Contract length: 12 months

Pay: From Php65,000.00 per month

Education:

  • Bachelor's (Required)

Work Location: On the road

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