Regulatory - Pharmacist

3 months ago


Jakarta, Indonesia Sante International Full time

Job Overview:
Key Responsibilities:

- Stay abreast of current regulations, guidelines, and industry trends to ensure compliance and provide regulatory guidance to project teams.
- Assist in the preparation and review of labeling, promotional materials, and other product-related documents to ensure compliance with regulatory requirements.
- Participate in regulatory agency interactions, including meetings, teleconferences, and written correspondence, to address inquiries and resolve regulatory issues.
- Conduct regulatory assessments of product changes, deviations, and quality issues, and provide recommendations for resolution.
- Support the development and implementation of regulatory strategies to expedite product approvals and optimize market access.
- Maintain regulatory databases, files, and records in accordance with company policies and regulatory standards.
- Assist in the preparation and review of standard operating procedures (SOPs), work instructions, and training materials related to regulatory compliance.
- Participate in internal and external audits and inspections, as necessary, and ensure timely resolution of any findings.

Qualifications:

- Bachelor of Pharmacy (Pharm.D.) or equivalent degree from an accredited institution. Advanced degree (e.g., Master of Pharmacy, Ph.D.) preferred.
- Registered pharmacist with current licensure to practice pharmacy in the relevant jurisdiction.
- Minimum of [X] years of experience in regulatory affairs within the pharmaceutical industry, preferably in a global regulatory environment.
- In-depth knowledge of regulatory requirements for drug development, registration, and post-approval activities in key markets (e.g., FDA, EMA, Health Canada, etc.).
- Strong understanding of pharmaceutical quality systems, Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP).
- Excellent analytical, organizational, and problem-solving skills, with meticulous attention to detail.
- Proven ability to collaborate effectively with cross-functional teams and communicate complex regulatory issues clearly and concisely.
- Ability to manage multiple priorities in a fast-paced environment and adapt to changing priorities and deadlines.
- Certification in Regulatory Affairs (e.g., RAC) desirable.

**Salary**: Rp8,000,000 - Rp10,000,000 per month


  • Warehouse Pharmacist

    2 months ago


    Jakarta, Indonesia Johnson & Johnson Full time

    PT Johnson And Johnson Indonesia Two is recruiting for a Warehouse Pharmacist, located in CCP Pulo Gadung PPG DC. Based on Food and Drugs Administration Regulation number 9 year 2019 about Technical Guideline of Good Drugs Distribution Practice / Petunjuk Teknis Cara Distribusi Obat yang Baik (CDOB) and number 6 year 2020 about Change of Food and Drugs...

  • Regulatory Supervisor

    3 months ago


    Jakarta, Indonesia PERSOLKELLY Indonesia Full time

    **Location**: - Jakarta- Jakarta**Work Type**: - Contract- University degree (BS or Master) with chemistry/ food technology/ pharmacy/ related disciplines. - At least 3 to 5 years relevant experience as Regulatory Affairs in Food Industry - Having Knowledge in ISO system, GMP, Food Safety Position : Regulatory Supervisor Location : Jakarta Raya Role...


  • Jakarta, Indonesia LUXASIA Full time

    LUXASIA is the leading beauty omnichannel distribution platform of Asia Pacific that has successfully enabled brand growth for more than 120 luxury beauty brands. Our integrated brand-building capabilities include luxury retail, online commerce, consumer marketing, and supply chain management. Since 1986, the company has partnered the world’s finest...


  • Jakarta, Indonesia Shiseido Full time

    MAIN PURPOSE This incumbent is responsible for managing the company’s regulatory scope to protect, grow and support the company’s business and reputation in the cosmetics industry. In this role, the incumbent is responsible for regulatory monitoring and lead or support the implementation of new regulations. The role will also require the incumbent be...


  • Jakarta, Jakarta, Indonesia Shiseido Full time

    MAIN PURPOSEThis incumbent is responsible for managing the company's regulatory scope to protect, grow and support the company's business and reputation in the cosmetics industry. In this role, the incumbent is responsible for regulatory monitoring and lead or support the implementation of new regulations. The role will also require the incumbent be...


  • Jakarta, Indonesia Amway Inc. Full time

    Job Summary We are seeking a highly motivated and detail-oriented Regulatory Affairs Executive to join our team. In this role, you will be responsible for ensuring compliance with all relevant regulations and standards governing our industry. You will work closely with Amway’s Global Innovation & Science team and collaborate with local cross-functional...


  • Jakarta, Indonesia LUXASIA Full time

    LUXASIA is the leading beauty omnichannel distribution platform of Asia Pacific that has successfully enabled brand growth for more than 120 luxury beauty brands. Our integrated brand-building capabilities include luxury retail, online commerce, consumer marketing, and supply chain management. Since 1986, the company has partnered the world’s finest...


  • Jakarta, Indonesia DKSH Full time

    **Location**:Jakarta, ID, ID**Job Function**:Regulatory Services**Requisition Number**:156030**Description**: **Job Summary** Supervise the execution of company quality assurance (QA), safety, health & environmental (SHE) and registration (REG) policies and standards, guarantee the regulatory compliance to local and international laws and...

  • Regulatory Affairs

    3 months ago


    Jakarta, Indonesia WeNetwork Asia Full time

    Our client is a B2B cosmetic company. As part of their business growth, they are currently looking for experienced Regulatory Affairs to increase their operations **Key Responsibilities**: - Reviewing cosmetics products regulations in Indonesia - Ensure all products have distribution permit - Monitoring all products sold have the right information on PDP -...

  • Executive, Pjt

    3 months ago


    Jakarta, Indonesia Colgate-Palmolive Full time

    No Relocation Assistance Offered 156710 - Jakarta, Jakarta, Indonesia **Who We Are** Colgate-Palmolive Company is a caring, innovative growth company that is reimagining a healthier future for all people, their pets and our planet. Focused on Oral Care, Personal Care, Home Care and Pet Nutrition, we sell our products in more than 200 countries and...

  • Regulatory Affairs

    3 months ago


    Jakarta, Indonesia BAXTER Full time

    **This is where you save and sustain lives** At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...

  • Regulatory Affairs

    3 months ago


    Jakarta, Indonesia In.Corp Indonesia Full time

    Responsible to register product to BPOM (cosmetic, health supplement, traditional medicine, food&beverage), Ministry of Health (medical device, household health supplies) and BPJPH (Halal). - Ensuring printed and soft copy document storage is accessible and searchable through. - Ensure that all information relating to the regulation up to date on an...

  • RAQA Lead

    2 weeks ago


    Jakarta, Jakarta, Indonesia Monroe Consulting Group Full time

    RAQA Lead Monroe Consulting Group Indonesia is recruiting on behalf of a Multinational Medical Device Company. Our client is seeking a highly skilled professional to lead their Quality Assurance and Regulatory Affairs teams. Responsibilities: Quality Assurance: Develop, implement, and maintain the company's quality management system...

  • RAQA Lead

    2 weeks ago


    Jakarta, Indonesia Monroe Consulting Group Full time

    Executive recruitment consultant Monroe Consulting Group Indonesia is recruiting on behalf of Multinational Medical Device Company. Our client is seeking for RAQA Lead position. This job will be based in Jakarta, Indonesia.Responsibilities:Quality Assurance:Lead the development, implementation, and maintenance of the company's quality management system (QMS)...


  • Jakarta, Indonesia LUXASIA Full time

    LUXASIA is the leading beauty omnichannel distribution platform of Asia Pacific that has successfully enabled brand growth for more than 120 luxury beauty brands. Our integrated brand-building capabilities include luxury retail, online commerce, consumer marketing, and supply chain management. Since 1986, the company has partnered the world’s finest...


  • Jakarta, Indonesia Reeracoen Indonesia Full time

    12,000,000 IDR ~ 30,000,000 IDR - Jakarta- Education: Bachelor’s Degree/Master’s Degree/Professional from Pharmacist/Apothecary/Chemistry/Chemical Engineering - Language: Ability to read, speak, write, and understands English. - Experience: 7 + years of fragrance evaluation experience in the FMCG industry. Additional business development and/or marketing...


  • Jakarta, Indonesia Lonza Full time

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...

  • Oq Batch Release

    3 months ago


    Jakarta, Indonesia Haleon Full time

    Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Panadol, Voltaren, and many more - through a unique combination of deep human understanding and...

  • Quality Executive

    3 months ago


    Jakarta, Indonesia Haleon Full time

    Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum - through a unique combination of deep...


  • Jakarta, Indonesia Pt B. Braun Medical Indonesia Full time

    You’re an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind,...