Regulatory Affairs Officer (6 Months)
By Hyphens Pharma International Ltd. At Jakarta Raya, Indonesia
To support the overall certification process for CDOB (GDP) and CDAKB (GDP for medical device).
Licensed pharmacist with working experience in regulatory affairs is preferred
Experience in handling SOPs and audit related to Medical device distributor licence and CDAKB (GDP for medical device) preferred
Possess good interpersonal and communication skills, positive attitude and result oriented
To help maintain, update and/or create SOPs related to the cosmetic distributor license, PBF and medical device distributor license.
To provide support during GDP audit by BPOM.
Regulatory Affairs Officer For New & Import Products
By PT Sanbe Farma At Bandung, Indonesia
Having experience in minimum 1 year (fresh graduated can also be considered).
Conducts any necessary negotiations with regulatory agencies during the registration process to expedite approval of product registration.
Ensures timely marketing authorization approval of new drugs, biological products, health supplements or medical devices.
Arranges labeling of each product being suitable with the current regulations.
Participates in product development plans as regulatory liaison.
Willing to locate in Bandung.
Indonesia Gcb Remainco Reporting And Regulatory Engagement Officer – C09
By Citi At Jakarta, Indonesia
Possesses relevant experience in operations especially in regulatory and management reporting preparation and submission.
Support any operational activities or project management related to residual GCB portfolio post business divestiture period
Partner with local and regional business management team to ensure alignment of business goals
Communicate business knowledge, product knowledge, and requirements to business and internal support functions
Consistently demonstrates clear and concise written and verbal communication skills, experienced in dealing and working with various stakeholders
Engage with appropriate regulatory bodies through relevant partners within country to ensure compliance towards applicable regulatory requirement.
Pjt/Regulatory Jobs
By Artha Inti Mentari At Kota Tangerang, Indonesia
Have an experience as PJT/Regulatory minimal 2 years and used to
Person in charge to Register in BPOM/KemKes and handle all related things.
Responsible for Warehouse activities : Inventory, Delivery team, Security & Hygiene and QC.
Supervise Manpower and provide regular Inventory/QC/BPOM/ Report.
Responsible for New Product Development (from Concept until Go-To-Market)
Candidate must S1 Bachelor Degree graduate in Pharmacy.
Regulatory Officer Jobs
By Siemens Healthineers At Jakarta, Indonesia
You have excellent communication skills to manage organization
You have a minimum 5 years of experience with regulations concerning in medical devices
You will be responsible to ensure all relevant regulatory system and databases are maintained up to date
You will be responsible to stay updated with the upcoming changes in regulatory and oversee the impact to the business
You will be responsible to build and maintain good relationship with regulatory bodies
You will monitor and support FSCA handling
Regulatory Affairs Officer Jobs
By PT. Radian Elok Distriversa At Jakarta, Indonesia
-At least 2 years of experiences in Regulatory Affair (Medical Device)
-Experience in Medical Devices product registration
-Prepare documents and apply for product registration
-Perform activities for IDAK, CDAKB, e-Katalog, OSS
-Bachelor Degree in any field (Pharmacy Major Preferred)
(new license and license maintenance)
Regulatory Affairs Officer Jobs
By SKINTIFIC At Jakarta Raya, Indonesia
Maintains and demonstrates an expert level knowledge and skill in products, quality systems, processes, and regulations.
Prepare and/or advise others on preparation of regulatory submissions for introduction of novel products in accordance with BPOM requirements.
Preferable with minimum 1-year of working experience in regulatory areas
Have knowledge in custom clearance would be a plus point
Develop and execute local, innovative regulatory strategies that will ensure compliance with local regulations.
Support and/or lead challenging communication situations internally or with external agencies/regulators to ensure business outcomes.
Regulatory Affairs Officer Jobs
By PT Ultra Sakti At Duri Utara, Indonesia

Company Description: PT Ultra Sakti is a pharmaceutical manufacturing and marketing company. The company was initially dedicated to manufacture pharmaceutical products in the form of standard and ...

Regulatory Jobs
By PT David Roy Indonesia At Jakarta, Indonesia

Company Description: PT David Roy Indonesia specializes in the distribution & innovative marketing of national and international food & beverage products. Job Description: Regulatory

Regulatory Officer & Pjtoh Jobs
By RAMANDA FIRM At Area DKI Jakarta, Indonesia

REGULATORY OFFICER & PENANGGUNG JAWAB TEKNIS OBAT HEWAN (PJTOH) Untuk Perusahaan Client Kami yang bergerak di Bidang Peternakan - PANCORAN - JAKARTA SELATAN Responsibilities : Bertanggung jawab ...

Regulatory Officer Jobs
By ABHATI GROUP At Duri Utara, Indonesia
Menjalankan proses Registrasi produk Obat Hewan ke Kementan RI
Menyiapkan kelengkapan dokumen dalam proses Registrasi
Menjalankan proses Quality Assurance/Regulatory dalam standar ISO 9001
Head Departement Regulatory Officer
By PT Mazta Farma At Kalideres, Indonesia
Minimum 2 years experience in the field of registration of cosmetics, supplements, medical devices, PKRT and Halal
Detail oriented, good communication skill and able to work under pressure
Graduate from Pharmacy / Biotechnology major
Understand the process of preparing DIP
Understand the priciples of CPKB, CPOTB, CDAKB, IDAK, CPPKRTB, Halal certificate
Able to negotiate with principals, BPOM, Ministry of Health, BPJPH
Regulatory Affairs Officer Jobs
By PT. Mutiara Mukti Farma At Medan Area, Indonesia
5.Has good communication skills and time management
3.Experience in similar position will be a plus.
6.Strong analytical capabilities, data analysis and problem solving
2.Min. Diploma degree of Pharmaceutical and Food Analysis (Bachelor and Apothecary profession are welcome to apply)
4.Attention to details, well-organized, and able to work under pressure
Regulatory Specialist Jobs
By Lonza At Indonesia

We are looking for a local Indonesian freelancer who is familiar with Department of Agriculture in Indonesia

Regulatory & Governance Officer Jobs
By PermataBank At Jakarta Raya, Indonesia
Have a minimum of 5 years work experience
Have a good analytical thinking skills.
Have a good communication and coordination skills, and be able to work with various work units in cross functions.
Prepare deep analysis in order to improve the quality of PermataBank's GCG implementation in accordance with applicable regulations and best practices.
Act as a resource person and perform advisory functions to related units regarding GCG, Company Law and Capital Market regulations.
Prepare and submit reports, both regular and incidental, including disclosure of information to the public.
Regulatory Bpom Jobs
By PT. Kafindo Cita Rasa At Jakarta Raya, Indonesia

Deskripsi Pekerjaan - Mendaftarkan produk pangan di BPOM sampai proses selesai - Update dengan peraturan BPOM - Mengerti alur proses registrasi di BPOM - Menyiapkan dokumen yang diperlukan untuk ...

Regulatory Staff Jobs
By CV Joil Tappa Arta At Area DKI Jakarta, Indonesia
Mengurus proses perizinan seperti SNI, Izin Edar, dan Izin Tipe sesuai dengan peraturan yang berlaku.
Bekerja sama dengan tim internal untuk mengumpulkan dan mempersiapkan dokumen yang diperlukan untuk pengajuan izin.
Menjaga komunikasi yang efektif dengan pihak berwenang terkait, seperti Badan Standardisasi Nasional (BSN) dan instansi terkait lainnya.
Melakukan pemantauan dan evaluasi terhadap peraturan terbaru yang berkaitan dengan perizinan dan memastikan perusahaan selalu mematuhi peraturan tersebut.
Menyediakan dukungan dan informasi kepada tim internal terkait perubahan peraturan dan persyaratan perizinan yang relevan.
Membantu dalam proses audit dan inspeksi yang dilakukan oleh pihak berwenang.
Regulatory Staff Jobs
By ABHATI GROUP At Duri Utara, Indonesia

Company Description: PT. Abhati Sie Sidarta (Abhati Group) adalah sebuah holding company yang bergerak dibidang trading bahan baku kimia, properti, hotel, dan manufacturing. Beberapa perusahaan ...

Regulatory Staff Jobs
By PT Neo Kosmetika Industri At Jatisampurna, Indonesia

1. Pendidikan SMK jurusan Farmasi/Analisis 2. Pengalaman min. 1 tahun sebagai regulatory staff 3. Melakukan notifikasi produk & mencari data pendukung 4. Membuat (Dokumen Informasi Produk) 5. ...

Packaging & Regulatory Officer Jobs
By Great Giant Foods At Jakarta, Indonesia
Generates and manages packaging improvement, cost and efficiency
Minimum 2 years experience in Packaging & Regulatory/ Packaging Development
Develops unique, innovative and sustainable packaging solution
Planning, monitoring and evaluating packaging related trials
Provides recommendation and advice across packaging specifications
Coordinating product registration process at BPOM (from preparation to approval)