Lowongan Kerja Jakarta Raya Posisi Regulatory Affairs Manager – Pharma / Medical Devices di PT Michael Page Internasional Indonesia

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Perusahaan	PT Michael Page Internasional Indonesia
Posisi	Regulatory Affairs Manager - Pharma / Medical Devices
Tempat	Jakarta Raya
Tingkatan Kerja	Manajer/Asisten Manajer
Kualifikasi	Diploma Pascasarjana, Gelar Professional, Magister (S2), Sarjana (S1)
Jenis Pekerjaan	Full Time
Spesialisasi Dibutuhkan	Manufaktur, Penjaminan Kualitas / QA
Gaji Min	Rp. 1.800.000
Gaji Max	Rp. 5.500.000

• Join a burgeoning company that is expanding in Indonesia.
• Be part of an industry that is growing aggressively.

Client Details

Our client is a multinational, publicly-listed, well-established, innovation-driven specialty pharma and medical devices company, with a compound annual turnover growth rate of over 20% over the past 10 years. They are currently market players in Asia within the dermatology, medical aesthetics, and consumer healthcare areas. They are expanding into Southeast Asia and are searching for a Product Manager to oversee their Ophthalmology related products’ marketing in Indonesia.

Description

• Responsible for local regulatory submissions plan
• Contribute to development of regulatory strategies for new products and changes to existing products in line with business objectives
• Product submissions, registration and compliance to international regulatory standards by preparation and submission of technical dossiers (ICH) or technical files to regulatory authorities in the country
• Manage compilation and submission of responses to queries raised during the evaluation process of NDAs through coordination with relevant parties
• Manage compliance of product labels and liaise with supply chain for the implementation in commercial shipments in the country
• Life cycle management of existing product portfolio to ensure regulatory compliance and licence renewals to support business needs
• Provision of regulatory advice to regulatory colleagues in the region and other colleagues in the organization
• Collation of information from the region for periodic safety updates reports
• Responsible for all regulatory operations that involve liaising work within the company functions such as Production, R&D and QA departments as well as external agencies such as health authorities in the country.
• Manage company regulatory affairs activities including reports, license transfers and renewals to ensure compliance with government requirements and company standards

Profile

• Pharmacy, Science degree or equivalent
• 5-10 years relevant working experience in RA settings in the country, product registrations and life cycle management
• Pharma experience
• Medical device experience a plus
• Quality experience a plus

Job Offer

Join a company on the verge of tremendous growth in Southeast Asia. Become a key member of the company’s structure and ambitious plans.

To apply online please click the ‘Apply’ button below. 

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Deskripsi Perusahaan

Info Perusahaan

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