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Other / Pharmaceutical / Prep / Training
Technical Responsible (Penanggungjawab Teknis) & Regulatory Associate (contract) (Jakarta, JK, ID) Full Time
This position will be responsible as the Technical Responsible Person (Penanggungjawab Teknis) & Regulatory Associate based in Jakarta, for ensuring all the relevant Regulatory compliances as applicable in Indonesia for wholesaling of cosmetics and medical devices. The person will primarily assist the South ASEAN Hub (SAH) Regulatory Affairs Manager in managing regulatory affairs matters related to Colgate products imported & marketed in Indonesia which includes product notification and registration with the respective health authorities and also halal certification application management with the Indonesia halal authority. The person will also assist the Colgate Palmolive South ASEAN Hub team in interactions with relevant government departments and authorities in Indonesia.
Specific Responsibilities:
1. Be the on-the-ground contact person for Colgate for coordinating with various regulatory authorities including on matters related to Post Market Surveillance
2. Support the SAH Regulatory Team in responding to enquiries and challenges from health authorities
3. Work with Regulatory consultants to prepare administrative documents to be signed off by PJT for purpose of cosmetics and/or medical device submissions
4. Participate in regular training related to Cosmetics and Medical Device Wholesalers business standards, as required of a Technical Responsible person in accordance to the relevant regulations
5. Assist SAH Regulatory Affairs Team Maintain Product Information File (PIF), technical information as well as other Regulatory documents in accordance with the provisions of the relevant regulations, in soft copy and at CPI office.
6. Keep abreast of Medical Device Good Distribution Practice and Cosmetic product requirements
7. Submit adverse event (MESKOS) and distribution record every 6 months to health authorities as required
8. Submit registration application submission for cosmetic products
9. Assist the Quality and Logistics functions in the implementation of the approved quality management system in accordance with the business standards of Cosmetic and Medical Wholesalers.
10. Ensure correctness and completeness of Regulatory information required for product procurement
11. Verify correctness and completeness of documents related to distribution, and destruction/disposal, as required.
12. Assist Quality, Logistics and other internal functions on product recall activities and communicate with authority on the recall status as and when required
13. Monitor and follow-up to ensure that customer complaints are addressed and closed by the responsible department.
14. Assist in the qualification and approval of suppliers and customers, as necessary.
15. If required, contribute to the drafting of agreement between the contract giver and the contract recipient related to the distribution of cosmetics and medical device
16. Provide inputs as appropriate in decisions to quarantine or destroy returned, damaged, recalled or suspected counterfeit Cosmetics
17. When required, ensure that self-inspections are conducted and ensure that necessary corrective and preventive actions are implemented as necessary.
18. Provide support to SAH Regulatory and CP Indonesia Team on other ID regulatory & halal administrative matters as instructed by the Regulatory Manager.
19. Review product label artwork and advertising materials including Bahasa translations
20. Engage with relevant government agencies, as and when required to support daily operations.
Qualifications :
1. DIII (Associate’s Degree) or S1 (Bachelor’s Degree) in Pharmacy or Pharmacist
2. A valid certificate of any of the following:
– Pharmacist Registration Certificate/ Surat Tanda Registrasi Apoteker (STRA) or
– Pharmaceutical Technical Personnel Registration Certificate /Surat Tanda Registrasi Tenaga Teknis Kefarmasian (STRTTK)
3. Having a Good Distribution Practice for Medical Device (GDPMD) training certificate will be an added advantage
Note: required as Colgate Palmolive Indonesia will be applying GDPMD certification
4. Having a recognized Halal Supervisor certificate will be an added advantage
5. Competency in English, verbal and written is necessary
Colgate-Palmolive is a leading global consumer products company, focused on Oral Care, Personal Care, Home Care and Pet Nutrition. Colgate sells its products in over 200 countries and territories around the world under such internationally recognized brand names as Colgate, Palmolive, Mennen, Softsoap, Irish Spring, Protex, Sorriso, Kolynos, Ajax, Axion, Soupline, and Suavitel. At our Hill’s Pet Nutrition division, makers of Science Diet® and Prescription Diet® brand pet foods, our mission is to help enrich and lengthen the special relationships between people and their pets by providing the best, leading-edge pet nutrition technology, products and expertise to pet owners, veterinary professionals and other key pet professionals worldwide. For more information about Colgate’s global business, visit the Company’s web sites on the Internet at www.Colgate.com and www.Hillspet.com.
This position will be filled without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, veteran status or any other characteristic protected by law.
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