Regulatory Affairs Executive

PT Kalventis Sinergi Farma


Tanggal: 1 hari yang lalu
Kota: Cirebon, West Java
Jenis kontrak: Penuh waktu
Responsibilities

Job & Responsibilities:

  • To prepare, review, and compile registration dossier based on company data file or applicable standard in accordance to local Health Authority requirements.
  • Prepare administrative document (such as covering letter, statement letter, payment etc.) for registration submission to local Health Authority.
  • Submit the registration document to local HA in timely manner.
  • To do verification active and inactive material, manufacturer in local HA database; follow up of verification and technical issue related e-registration system to local HA.
  • Follow the registration submission status in local HA application system.
  • Ensuring all information and data in company database are updated.
  • Communicate deficiency/any queries from local HA to principal.
  • Submit Response for deficiency in timely manner.
  • Keep updated with new regulatory policies.
  • Maintain accuracy of product labeling to comply with the global and local requirement.
  • Ensure appropriate training has been conducted.
  • To support and assist Regulatory Affairs Manager as necessary.

Requirements

Qualifications & Requirements:

  • Bachelor's degree in Pharmacy/ Pharmaceutical Sciences. Having a Pharmacist degree is much preferred.
  • Specialized courses or certifications in regulatory affairs would be advantageous.
  • At least 3-5 years of experience in regulatory affairs within the pharmaceutical, biotechnology industry.
  • Hands-on experience with compiling registration dossiers, submission processes, and interacting with Health Authorities.
  • Prior experience in maintaining product labeling to comply with global and local requirements is desirable.
  • Comprehensive understanding of local and international regulatory requirements and guidelines related to pharmaceuticals
  • Strong knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
  • Knowledge and adherence to relevant laws, regulations, and guidelines governing the pharmaceutical, biotechnology, or medical device industry.
  • Experience in ensuring compliance with regulatory requirements throughout the product lifecycle, including registration, post-market

Cara melamar

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