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Regulatory Affairs Officer Jobs

Regulatory Affairs Jobs
By Bosch ASEAN At Jakarta, Indonesia
Having project management skills and willing to do paperwork/administrative tasks
Bachelor’s degree in Public Administration Service / Law / Business Administration / Management
Good understanding of regulatory and certification processes
3-5 years of experience in the area of regulatory affairs and/or compliance
Being well-connected to the Ministry of Industry, Ministry of Communications and/or certifications bodies is a plus point
Monitor and provide regular updates on the regulatory environment that are relevant to the Bosch business
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 Manager Jobs
By PT. Satoria Aneka Industri At Jakarta Raya, Indonesia

Kualifikasi : Pendidikan S1 Farmasi / Profesi Apoteker Pengalaman menjadi asisten manajer untuk produk farmasi import dan export Memiliki pengetahuan teknis mengenai registrasi export/import atas ...

Regulatory Affairs Manager Jobs
By PT Tempo Scan Pacific Tbk At Jakarta, Indonesia
Memahami kemampuan project management dan time management yang baik
Memiliki kemampuan komunikasi dan interpersonal skill yang baik
Bertanggung jawab atas penyusunan self assessment dan verifikasi kelengkapan data/dokumen/sampel untuk registrasi SKI (Surat Keterangan Import)
Bertanggung jawab memastikan seluruh registrasi SKI (Surat Keterangan Import) dan Perijinan di Tempo Scan Group dapat terlaksana sesuai target yang ditetapkan.
Secara berkala melakukan update informasi/regulasi yang berkaitan dan berdampak kepada perijinan Tempo Scan Group.
Menjaga hubungan baik dengan pihak eksternal seperti BPOM, Kemenkes, Dinkes dan melakukan follow up terkait penyelesaian perijinan / sertifikasi
Regulatory Affairs Manager Jobs
By Robert Walters At Area DKI Jakarta, Indonesia
Strong knowledge of biopharmaceuticals and Cell and Gene therapy regulations, including key markets (US, EU, Japan, South Korea)
Proficient in English and excellent communication skills
Experience preparing INDs and NDAs, and related amendments and supplements in Indonesia
About The Regulatory Affairs Manager Role
Analyse emerging developments to provide strategic and scientific insights, ensuring the regulatory framework remains adaptive and responsive
Lead discussions and provide advice to stakeholders on efficient pre-clinical, quality, and clinical development, supporting local product registration efforts
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.
Compliance And Regulatory Affairs
By Mulyatek Kreasi Andalan At Kota Tangerang, Indonesia
Menjalankan seluruh kegiatan mengenai kepatuhan regulasi seperti dokumentasi, registrasi, dan kepatuhan lainnya.
Berhubungan baik dengan lembaga yang berkaitan dengan kepatuhan termasuk BPOM, OSS, MUI, Kemnaker.
Melaksanakan seluruh proses regulasi yang untuk keperluan registrasi produk makanan ringan sampai dengan persetujuannya.
Bertanggungjawab dalam dokumentasi dan perijinan mengenai semua keperluan regulasi termasuk BPOM, OSS, Menkes, Kemnaker.
Membantu proses audit perusahaan dan penyelesaian temuannya.
Memastikan fasilitas dan perusahaan memenuhi standar regulasi.
Regulatory Affairs Lead (Medical Devices)
By Robert Walters At Area DKI Jakarta, Indonesia
Minimum of eight years' experience in regulatory affairs within the medical devices industry, with specific experience in Indonesia's regulatory environment
Develop and execute comprehensive regulatory strategies for the successful clearance and approval of medical devices
Collaborate with cross-functional teams to gather necessary technical and clinical data for submissions
Bachelor's degree in a relevant scientific or engineering discipline; advanced degree preferred
Proven track record of successful product registrations and approvals in Indonesia, including interactions with regulatory authorities
Proficiency in English and Indonesian languages, both written and spoken
Regulatory Affairs Executive Jobs
By ParagonCorp At Jakarta Raya, Indonesia
Apothecary Profession with minimum 5 years of working experience in product licensing, registration, and certification
Ability to work independently in a team environment, organized, good time management, and deadline driven.
Good interpersonal and communication skills-- proficient in English and verbal and written communication, negotiate and persuade
Ability to build relationships with internal dan external stakeholders
Please submit your CV & Portfolio on your Profile.
Regulatory Affairs Specialist Jobs
By Whitelab - Deca Group At Jakarta Utara, Indonesia
Strong project management skills, including the ability to manage multiple projects simultaneously.
Have a good knowledge in regulatory compliance, regulatory system (PKRT, BPOM, halal certification)
Minimum experience of 3 years in handling Regulatory
Experience for handling & dealing with Government Agencies (audit, inspection)
Preferably has experience in preparing documents of import and reports requested by Government Agency
Excellent communication and interpersonal skills to collaborate with cross- functional teams and external suppliers, negotiation and administrative skills
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 ...

Ppgr Regulatory Affairs Jobs
By Gojek At Jakarta, Indonesia
Strong writing and presentation skills and the ability to synthetase complex policy issues in digestible policy brief memos for senior executives/management
Advise Senior Executives and the Board of Management in managing the regulatory, relationship, and issues that could impact Gojek Logistic business
Build and manage a network of key government stakeholders and relationships to help shape a positive policy and regulatory environment
Strong organizational and analytical skills in order to cover multiple parallel running strategies
Ability to multitask, deal with and lead discussions with multiple internal stakeholders (legal, compliance, corporate, and finance)
Collaborate effectively with cross-functional leadership to shape Gojek’s overall positions on key policy topics
Regulatory Affairs Specialist Jobs
By Roche At Jakarta, Indonesia
Liaise and establish cooperative relationships with relevant regulatory colleagues to ensure understanding of regulatory requirements in Indonesia and
Bachelor of Pharmacy or Science with Pharmacist certification.(S.Si. Apt or S.Fam, Apt) is strongly preferred
At least 2-3 year(s) of working experiences as Regulatory affairs in healthcare business (preference on Medical device or diagnostic industry)
Excellent Interpersonal skills with the ability to build working relations both internally and externally
Request the documentation required for registration submissions for new registration, line extension, change to registered products/variants and product renewal
Build constructive relationships with the local health authority by compiling and submitting high quality submissions and providing prompt responses to questions
Legal And Regulatory Affairs Intern (Remote)
By Flip At Area DKI Jakarta, Indonesia
Excellent verbal and written communication skills
Assist in the Know Your Business (KYB) checking conducted by the Company towards its candidate users
Conduct legal research related to legal matters or issues relevant to the Company's business
Support legal and compliance documentation of the Company
General administration works as needed by the team
Fresh graduate of law (Final semester students with no classes to attend are welcome to apply)
Regulatory Affairs Manager Jobs
By PT Pyridam Farma Tbk At Cikarang Pusat, Indonesia
At least 10 years of Regulatory Affairs relevant working experience in Pharmaceutical Manufacturing industry.
Experienced in the process of registration of cosmetics, supplements, medical devices, PKRT
Excellent written and verbal communication skills (Bahasa & English)
Manage regulatory compliance of all product component (raw material, composition, manufacturing process, specification and packaging).
Manage renewals and variations applications for existing products
Taking care of regulatory assessment (regulations/registration requirements, key documents for registration, patent and trademark if needed).
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 Affairs Executive Jobs
By PT. Softex Indonesia At Kota Tangerang, Indonesia
To support the RA manager in generating product and facility licensing registration to support local/regional business objectives.
Ensure a qualified Halal/product/facility registration dossier is prepared and meeting with the most current requirements in timely manner
Having 1-2 years experiences in Medical Device and Household product registration and dealing with related government agencies, i.e.: BPOM, Kemenkes.
Knowledgeable with related regulations of Medical Device and Household product registration and corresponding activities (BPOM, Kemenkes).
Strong verbal and written communication skills, fluency in English.
To generate Halal registration strategy and planning to ensure compliance with both company and relevant local regulations (i.e.: changes, renewals)

Are you looking for an exciting opportunity to make a real difference in the healthcare industry? We are looking for a Regulatory Affairs Officer to join our team and help us ensure that our products meet all regulatory requirements. If you have a passion for regulatory compliance and a drive to make a positive impact, this could be the perfect job for you!

Overview: Regulatory Affairs Officers are responsible for ensuring that a company’s products and services comply with all applicable laws and regulations. They work closely with other departments such as research and development, marketing, and legal to ensure that products meet the necessary standards. They also provide advice and guidance on regulatory issues, and monitor changes in the regulatory environment. How to Become a Regulatory Affairs Officer: To become a Regulatory Affairs Officer, you must have a bachelor’s degree in a related field such as biology, chemistry, or engineering. You may also need to have experience in the field, such as working in a laboratory or in a regulatory agency. Regulatory Affairs Officer Skills: Regulatory Affairs Officers must have strong analytical and problem-solving skills, as well as excellent communication and interpersonal skills. They must also be able to work independently and as part of a team. Regulatory Affairs Officer Knowledge: Regulatory Affairs Officers must have a thorough understanding of the laws and regulations that apply to their company’s products and services. They must also be familiar with the relevant industry standards and guidelines. Regulatory Affairs Officer Responsibilities: Regulatory Affairs Officers are responsible for ensuring that a company’s products and services comply with all applicable laws and regulations. They must also provide advice and guidance on regulatory issues, and monitor changes in the regulatory environment. Regulatory Affairs Officer Experience: Regulatory Affairs Officers must have experience in the field, such as working in a laboratory or in a regulatory agency. Regulatory Affairs Officer Qualifications: Regulatory Affairs Officers must have a bachelor’s degree in a related field such as biology, chemistry, or engineering. Regulatory Affairs Officer Education: Regulatory Affairs Officers must have a thorough understanding of the laws and regulations that apply to their company’s products and services. They must also be familiar with the relevant industry standards and guidelines. Tools to Help Regulatory Affairs Officer Work Better: Regulatory Affairs Officers can use software such as Microsoft Office, Adobe Acrobat, and other document management systems to help them manage their work. They can also use online databases to stay up-to-date on the latest regulations. Good Tips to Help Regulatory Affairs Officer Do More Effectively: Regulatory Affairs Officers should stay organized and keep detailed records of their work. They should also be proactive in researching new regulations and staying up-to-date on changes in the regulatory environment.

Common Regulatory Affairs Officer Interview Questions:

• What experience do you have in regulatory affairs?
• How do you stay up-to-date on changes in the regulatory environment?
• What challenges have you faced in regulatory affairs?
• How do you ensure that a company’s products and services comply with all applicable laws and regulations?
• What strategies do you use to ensure compliance?