Lowongan Kerja Jakarta Raya Posisi Regulatory Affairs Junior Manager – Based In Indonesia di PT Michael Page Internasional Indonesia

Info Loker

Perusahaan	PT Michael Page Internasional Indonesia
Posisi	Regulatory Affairs Junior Manager - Based In Indonesia
Tempat	Jakarta Raya
Tingkatan Kerja	Manajer/Asisten Manajer
Kualifikasi	D3 (Diploma), D4 (Diploma), Sarjana (S1), Sertifikat Professional
Jenis Pekerjaan	Full Time
Spesialisasi Dibutuhkan	Pelayanan, Pengacara / Asisten Legal
Gaji Min	Rp. 1.800.000
Gaji Max	Rp. 5.500.000

• The candidate should have good networking with the government such as BPOM.
• The candidate should know and be updated about laws and regulations regarding the pharmaceutical industry.

Client Details

• Our client is a Korean conglomerate company, one of the leaders within its pharmaceutical industry.
• Due to their expansion and growth plan, they looking for someone who has experience in regulatory affairs who is able to speak English to be part of their team.

Description

RESPONSIBILITIES

– Provide regulatory leadership assistance to drive the review, development, and implementation of regulatory and legislative policies, scientific and technical standards, industry guidelines, and good practices for GMP, clinical trials, and registration of Cell and Tissue Therapy Products and/or chemical products.

– Environmental monitoring with a view to providing strategic and scientific inputs to ensure the regulatory framework is responsive to emerging developments.

– Lead regulatory and scientific discussions and advice to stakeholders on the efficient pre-clinical, quality, and clinical development of Cell and Tissue Therapy Products, with a view to supporting local product registration.

– Represent HQ as a technical expert at regional and international meetings, to influence strategic directions and desired technical and scientific outcomes of interest.

– Develop, standardize, execute, and approve all regulatory documentation. associated with products in the assigned portfolio to meet compliance. requirements of appropriate Indonesian regulatory bodies.

– Based in Jakarta with occasional assignment to Cikarang.

Profile

[Experience and Knowledge]

1. At least 6 years of experience as a regulatory consultant or equivalent scope of work in biopharmaceuticals or/and Cells & Gene therapy (ex. Stem cell, etc.), chemical products.

2. Demonstrates in-depth scientific knowledge of the biopharmaceuticals, Cells & Gene therapy (ex. Stem cell, etc.) field, including the scientific advancement and developments in this space, and the ability to provide strong and effective professional and scientific leadership.

3. Demonstrates a high level of knowledge on the regulatory considerations in biopharmaceuticals, Cells & Gene therapy (ex. Stem cell, etc.) regulation, and the regulatory frameworks in major overseas markets e.g. US, EU, Japan, and South Korea.

4. Demonstrates a high level of competence in strategy and policy development in biopharmaceuticals, Cells & Gene therapy (ex. Stem cell, etc).

5. Understanding and knowledge of Indonesian regulations related to cell and biopharmaceuticals.

[Skills]

1. Bachelor’s Degree or higher graduate degree from the Pharmacy/Biology background and/or discipline.

2. Ability to communicate confidently and diplomatically with various stakeholders.

3. Excellent written and spoken English.

4. Relevant experience in participating in international scientific advisory committees/workgroups for Cell and Tissue Therapy.

5. Experience and knowledge in preparation of INDs and NDAs, and supportive amendments and supplements (nonclinical, clinical) in Indonesia.

Job Offer

• Opportunity for Growth and Learning (new drugs, biopharmaceuticals, and cosmetics).
• Good package
• Good career path and new experience

Lamar kerja

Deskripsi Perusahaan

Info Perusahaan

• Industri: Manajemen/Konsulting HR
• Ukuran Perusahaan: 51 - 200 pekerja
• Lokasi: Jakarta Raya, Jawa Barat