Regulatory Affairs Executive

PT Kalventis Sinergi Farma

Tanggal: 3 minggu 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

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