Regulatory Affairs Supervisor

PT Darya Varia Laboratoria, Tbk; Daerah Khusus Ibukota Jakarta; On-site; IDR 100.000.000 - 200.000.000; Full time

Job summary

PT Darya Varia Laboratoria, Tbk is looking for a Regulatory Affairs Supervisor to oversee product registration processes ensuring compliance with regulations. The ideal candidate will have at least 3 years of experience in regulatory affairs, excellent interpersonal and communication skills, and the ability to manage projects effectively.

Qualifications

• Minimum 3 years in regulatory affairs, handling food and medical device registrations.
• Strong knowledge of local regulations and product registration requirements.
• Proficiency in English required.

Responsibilities

• Monitor and execute the registration process for products.
• Coordinate with departments to prepare registration documents and submit to BPOM/Kemenkes.
• Ensure compliance with regulations and achieve approval within timelines.

Skills

Interpersonal skills

Detail-oriented

Communication

Negotiation

Project management

Job description

• Execute & monitoring registration process
• Coordination with related department and Principals, registration document request, review documents & prepare good registration dossier, do registration submission to BPOM/Kemenkes system, including additional data fulfillment, monitor & follow up the registration process until getting the approval (if needed negotiation with BPOM/Kemenkes)
• Ensure all regulatory activities (new product, variation & renewal submission) are comply with current regulations, requirements and practices.
• Ensure to get approval as committed timeline
• Liaise with Manager & Dept. Head to get advises on regulatory strategy and approach.
• Develop good relations with internal & external stake holders.

JOB REQUIREMENTS :

- Has experiences in regulatory affairs min 3 years handling registration process for categories of processed food, medical devices, health supplement, cosmetics, traditional medicines & advertisement registration.
- Knowledge of the local regulatory affairs environment and how this impacts regulatory strategy and implementation, especially related to product registration requirements, regulations & quidelines.
- Strong interpersonal skills.
- Detail-oriented with the ability to manage projects from inception through execution and tracking progress of projects to completion
- Proficiency in English both, written and spoken
- Good communication & negotiation skill
- Loyal & has a good responsibility, good teamwork
- Positive attitude
- Fast learning

Which of the following languages are you fluent in?

What's your expected monthly basic salary?

How many years of project management experience do you have?

Which of the following types of qualifications do you have?

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Pharmaceuticals, Biotechnology & Medical 1,001-5,000 employees

PT Darya-Varia Laboratoria Tbk ("Darya-Varia" or "the Company") is a long-established pharmaceutical company in Indonesia that first commenced its operations in 1976. Upon becoming a public company in 1994, it acquired PT Pradja Pharin (Prafa) in 1995, and proceeded to develop a wide range of Prescription and Consumer Health products. In July 2014, Darya-Varia merged with Prafa.

Darya-Varia operates two world-class manufacturing facilities, one in Gunung Putri and one in Citeureup, Bogor, both of which are ASEAN current Good Manufacturing Practice (cGMP) certified. The two plants are focused on manufacturing the Company's own brands, as well as toll manufacturing products for national and multinational principals, both for local and export markets.

The Darya-Varia Plant in Gunung Putri specializes in manufacturing soft gelatin capsules and liquid products, while the Darya-Varia Plant in Citeureup concentrates on the manufacturing of sterile injections and solids. The Company also toll manufactures with its affiliate, PT Medifarma Laboratories, at Cimanggis Plant, Depok. In 2013, the Company obtained halal certification for NATUR-E and HOBAT Capsules, its animal based gelatin products, marking a first halal certified supplement for a pharmaceutical company in Indonesia.

In line with its mission to "build a healthier Indonesia one person at a time", Darya-Varia produces high quality products for both Consumer Health and Ethical product lines, building strong, respected brands that are recognized throughout Indonesia. By following a consistent and relationship-driven engagement approach, the Company is moving to achieve its vision to be a top-five pharmaceutical company in Indonesia.

Currently 92.66% of Darya-Varia shares is owned by Blue Sphere Singapore Pte. Ltd. (BSSPL), an affiliate of United Laboratories, Inc. (Unilab).Unilab, the Philippines' largest pharmaceutical company, was established in 1945 and now has a large network of Asian affiliates including operations in Indonesia, Vietnam, Myanmar, Thailand, Malaysia, Singapore, Laos, Cambodia and China.

PT Darya-Varia Laboratoria Tbk ("Darya-Varia" or "the Company") is a long-established pharmaceutical company in Indonesia that first commenced its operations in 1976. Upon becoming a public company in 1994, it acquired PT Pradja Pharin (Prafa) in 1995, and proceeded to develop a wide range of Prescription and Consumer Health products. In July 2014, Darya-Varia merged with Prafa.

Darya-Varia operates two world-class manufacturing facilities, one in Gunung Putri and one in Citeureup, Bogor, both of which are ASEAN current Good Manufacturing Practice (cGMP) certified. The two plants are focused on manufacturing the Company's own brands, as well as toll manufacturing products for national and multinational principals, both for local and export markets.

The Darya-Varia Plant in Gunung Putri specializes in manufacturing soft gelatin capsules and liquid products, while the Darya-Varia Plant in Citeureup concentrates on the manufacturing of sterile injections and solids. The Company also toll manufactures with its affiliate, PT Medifarma Laboratories, at Cimanggis Plant, Depok. In 2013, the Company obtained halal certification for NATUR-E and HOBAT Capsules, its animal based gelatin products, marking a first halal certified supplement for a pharmaceutical company in Indonesia.

In line with its mission to "build a healthier Indonesia one person at a time", Darya-Varia produces high quality products for both Consumer Health and Ethical product lines, building strong, respected brands that are recognized throughout Indonesia. By following a consistent and relationship-driven engagement approach, the Company is moving to achieve its vision to be a top-five pharmaceutical company in Indonesia.

Currently 92.66% of Darya-Varia shares is owned by Blue Sphere Singapore Pte. Ltd. (BSSPL), an affiliate of United Laboratories, Inc. (Unilab).Unilab, the Philippines' largest pharmaceutical company, was established in 1945 and now has a large network of Asian affiliates including operations in Indonesia, Vietnam, Myanmar, Thailand, Malaysia, Singapore, Laos, Cambodia and China.