Part Leader Regulatory Affair

Farmasi (Kesehatan & Medis); Daerah Khusus Ibukota Jakarta; On-site; IDR 300.000.000 - 400.000.000; Full time

Job summary

Perusahaan Farmasi di Jakarta membuka lowongan untuk 'Part Leader Regulatory Affair' yang akan memimpin tim di bidang penelitian dan inovasi. Posisi ini membutuhkan gelar sarjana di bidang farmasi dan pengalaman minimal 7 tahun dalam regulasi produk kosmetik. Tanggung jawab utama termasuk pendaftaran produk dan memastikan kepatuhan terhadap semua regulasi yang relevan.

Qualifications

• Min 7 years as a Senior Staff/Supervisor Regulatory Affair.
• In-depth knowledge of registration processes.
• Fluent in English (both spoken & written).

Responsibilities

• Ensure product registration to BPOM Ri and other certifications.
• Conformity of legal, statutory, and regulatory requirements.
• Prepare Product Information File for ODM products.

Skills

Detail orientation

Time management

Analytical skills

Education

Bachelor degree of Pharmacy, Apothecary, Chemistry or related major

Tools

ISO 9001

ISO 22716

CPKB

Job description

COSMAX is the Global No.1 ODM, OEM, OBM manufacturer for K-Beauty & Health products. With production facilities and a high-end R&I center located in Indonesia, we are uniquely positioned to supply cosmetics, health products and functional foods to a wide range of global partners.

PT. Cosmax Indonesia is A subsidiary of COSMAX Group, the global leader in Korean beauty and health products. Trusted by over 600 beauty companies over the world, including 15 of the world’s Top 20 beauty brands.

PT. Cosmax Indonesia growth very fast and to reach our commitment more , we are open opportunity for Part Leader Regulatory Affair .

Part Leader Regulatory Affair will be lead team RNI (Research & Innovation) consist of more than 10 person in this team as follows : Staff Regulatory Affairs, Staff Raw Material, Staff Efficacy, others. As Part Leader Regulatory Affairs will be direct report to Team Leader Regulatory Affairs & General Manager RNI (from South Korea) . Please read the qualification below before you apply this position

Disclaimer: The selection process will be conducting offline interview in Jl TB Simatupang, South Jakarta & Ciracas, East Jakarta. Ensure that you able to attend the selection process with our procedure

Part Leader Regulatory Affairs
Qualifications :

Bachelor degree of Pharmacy, Apothecary, Chemistry or related major.

Have experience min 7 years as a Senior Staff/Supervisor Regulatory Affair in cosmetics or house hold industries

In dept knowledge of cosmetics & house hold product’s registration processes

Have high interest & enthusiasm for cosmetics, regulatory landscape with strong commitment product safety & compliance

Comprehensive knowledge of relevant cosmetics regulation (both local & international standards)

Up to date for the compliance & regulatory trends

Good & wide relationships with BPOM, Ministry of Health, and others relevant parties

Skilled in analyzing regulations

Fluent in English (both spoken & written)

Detail orientation person

Good in time management , able to work with deadlines

Familiar with Key Regulatory Standards, ISO 9001, ISO 22716, CPKB, BPOM, Halal Product Assurance Systems, ISO 14001, ISO 45001

Role & Responsibilities :

Conformity of legal, statutory, and regulatory with refer government regulations

Ensure product registration to BPOM RI, Ministry of Health, HALAL Registration(LPPOM & BPJPH), Vegan Verification, COSMOS certification meet requirement &time line

Ensure the compliness of labelling information of the products

Ensure the preparation of Product Information File for ODM products

Perform HALAL certification or others certification as required standard from clients

How would you rate your English language skills?

What's your expected monthly basic salary?

Which of the following types of qualifications do you have?

Are you willing to undergo a pre-employment background check?

Are you willing to undergo a pre-employment medical check?

How much notice are you required to give your current employer?

How many years' experience do you have as a Regulatory Affairs Executive?

How many years' experience do you have as a Head of Regulatory Affairs?

Manufacturing, Transport & Logistics 51-100 employees

Established in 1992 in Korea, Cosmax Inc. is a leading Korean cosmetics R&D and contract manufacturer. Recording sky-rocketing growth since its foundation, Cosmax Inc. has expanded its business not only in Korea but in overseas markets, such as China (Shanghai and Guangzhou), Indonesia and USA.

PT. Cosmax Indonesia, established in 2011, is a wholly owned subsidiary of Cosmax Inc. and is developing its business in Indonesia as well as in Southeast Asia.

The company develops new cosmetics products for brand company (ODM : Original Design Manufacturing) or does toll-manufacturing for brand companies' existing cosmetics products (OEM : Original Equipment Manufacturing)

With strong collaboration with leading global cosmetics brands and many of Korean brands, PT. Cosmax Indonesia has been expanding its business, thus the company seeks for Indonesian talents.

Product & Services

The Products of the PT. Cosmax Indonesia is not only the tangible cosmetics products.

Not like the conventional OEM companies (or toll manufacturing company), PT. Cosmax Indonesia is doing ODM, providing its customers with high quality cosmetics formulation, semi-finished goods and finished goods (with the brands of the client's)

To summarized, PT. Cosmax Indonesia is a total solution provider for cosmetics brands.

Established in 1992 in Korea, Cosmax Inc. is a leading Korean cosmetics R&D and contract manufacturer. Recording sky-rocketing growth since its foundation, Cosmax Inc. has expanded its business not only in Korea but in overseas markets, such as China (Shanghai and Guangzhou), Indonesia and USA.

PT. Cosmax Indonesia, established in 2011, is a wholly owned subsidiary of Cosmax Inc. and is developing its business in Indonesia as well as in Southeast Asia.

The company develops new cosmetics products for brand company (ODM : Original Design Manufacturing) or does toll-manufacturing for brand companies' existing cosmetics products (OEM : Original Equipment Manufacturing)

With strong collaboration with leading global cosmetics brands and many of Korean brands, PT. Cosmax Indonesia has been expanding its business, thus the company seeks for Indonesian talents.

Product & Services

The Products of the PT. Cosmax Indonesia is not only the tangible cosmetics products.

Not like the conventional OEM companies (or toll manufacturing company), PT. Cosmax Indonesia is doing ODM, providing its customers with high quality cosmetics formulation, semi-finished goods and finished goods (with the brands of the client's)

To summarized, PT. Cosmax Indonesia is a total solution provider for cosmetics brands.