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Regulatory Affairs jobs in Malaysia

Regulatory Affairs Specialist II

Regulatory Affairs Specialist II
Johnson & Johnson
Petaling Jaya
MYR 60,000 - 90,000
Urgently required
2 days ago
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Regulatory Executive

Regulatory Executive
PharmEng Technology Pte Ltd
Kuala Lumpur
MYR 200,000 - 250,000
Urgently required
2 days ago

Regulatory Affairs Executive

Regulatory Affairs Executive
Vitahealth
Selangor
MYR 200,000 - 250,000
Urgently required
2 days ago

Regulatory Affairs Manager

Regulatory Affairs Manager
Dr Clear Aligners
Kuala Lumpur
MYR 200,000 - 250,000
Urgently required
2 days ago

Senior / Regulatory Affairs Executive

Senior / Regulatory Affairs Executive
Ambu Sdn. Bhd.
Bayan Lepas
MYR 48,000 - 72,000
Urgently required
Yesterday
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Regulatory Affairs Specialist (Cosmetics & Pharmaceutical Product) MY SG Brunei

Regulatory Affairs Specialist (Cosmetics & Pharmaceutical Product) MY SG Brunei
Persolkelly
Selangor
MYR 100,000 - 150,000
Urgently required
2 days ago

Senior Regulatory Affairs Executive

Senior Regulatory Affairs Executive
MR DIY International
Seri Kembangan
MYR 200,000 - 250,000
Urgently required
Yesterday

Regulatory Affairs Executive

Regulatory Affairs Executive
Hebe Beauty
Selangor
MYR 200,000 - 250,000
Urgently required
2 days ago
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Regulatory Affairs Specialist (Medical Device-APAC)

Regulatory Affairs Specialist (Medical Device-APAC)
Randstad Malaysia
Kuala Lumpur
MYR 60,000 - 90,000
Urgently required
2 days ago

Regulatory Affairs

Regulatory Affairs
Thermo Fisher Scientific
Shah Alam
MYR 70,000 - 90,000
Urgently required
2 days ago

Manager, Group Prudential Supervision & Regulatory Affairs

Manager, Group Prudential Supervision & Regulatory Affairs
Kenanga Investment Bank
Kuala Lumpur
MYR 200,000 - 250,000
Urgently required
2 days ago

Food Packaging Regulatory Technologist (Europe)

Food Packaging Regulatory Technologist (Europe)
Kerry Group plc
Petaling Jaya
MYR 60,000 - 80,000
Urgently required
2 days ago

Regulatory Technologist

Regulatory Technologist
Kerry Group plc
Petaling Jaya
MYR 100,000 - 150,000
Urgently required
2 days ago

Regulatory Affairs & Product Compliance Executive

Regulatory Affairs & Product Compliance Executive
Mr D.I.Y. Group
Seri Kembangan
MYR 100,000 - 150,000
Urgently required
2 days ago

Regulatory Affairs Executive

Regulatory Affairs Executive
GN Neutriceuticals
Subang Jaya
MYR 200,000 - 250,000
Urgently required
Today

Senior Finance Manager

Senior Finance Manager
Vinda SEA
Malaysia
MYR 120,000 - 180,000
Urgently required
Today

Coutry Brand Manager, Vaccines

Coutry Brand Manager, Vaccines
Pfizer, S.A. de C.V
Kuala Lumpur
MYR 120,000 - 180,000
Urgently required
Today

Logistics and Warehouse Officer

Logistics and Warehouse Officer
NOREL
Pasir Gudang
MYR 100,000 - 150,000
Urgently required
Yesterday

Coutry Brand Manager, Vaccines

Coutry Brand Manager, Vaccines
Pfizer
Kuala Lumpur
MYR 120,000 - 180,000
Urgently required
Yesterday

Quality & Compliance Officer - Pet Food

Quality & Compliance Officer - Pet Food
Addiction Foods NZ Ltd.
Rawang
Remote
MYR 60,000 - 80,000
Urgently required
Yesterday

Head of Government Affairs (Automotive OEM)

Head of Government Affairs (Automotive OEM)
Michael Page
Kuala Lumpur
MYR 120,000 - 180,000
Urgently required
2 days ago

Product Training Manager – Health Supplements

Product Training Manager – Health Supplements
Cambert (M) Sdn Bhd
Subang Jaya
MYR 100,000 - 150,000
Urgently required
2 days ago

Food Technologist / R&D Specialist

Food Technologist / R&D Specialist
Serba Wangi
Alor Setar
MYR 100,000 - 150,000
Urgently required
Today

Assistant QAQC Manager

Assistant QAQC Manager
Encompass Industries
Kerteh
MYR 70,000 - 90,000
Urgently required
Yesterday

Director, Strategic Communications

Director, Strategic Communications
Malaysia Digital Economy Corporation (MDEC)
Cyberjaya
MYR 120,000 - 180,000
Urgently required
2 days ago

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Regulatory Affairs Specialist II

Be among the first applicants.
Johnson & Johnson
Petaling Jaya
MYR 60,000 - 90,000
Be among the first applicants.
3 days ago
Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Petaling Jaya, Selangor, Malaysia

Job Description:

The Regulatory Affairs Specialist II MD is a member of the local Regulatory Affairs department, responsible for actively contributing to the regulatory compliance of medical devices products under their responsibility. The position is responsible for providing input into the global regulatory strategy and identifying country requirements for successful regulatory filings for new products/indications and line extensions.

Key Responsibilities:

  • The Regulatory Affairs Specialist will be a member of the local Regulatory Affairs department within Johnson & Johnson Sdn Bhd, Malaysia, with responsibility for regulatory aspects of the assigned product portfolio/s or Projects.

  • Preparation of submissions to the local health authority for new products and variations to existing products in line with Marketing launch plans.

  • Maintain departmental and source company databases of regulatory approvals. Labelling and promotional material review as required.

  • Liaise and establish cooperative relationships with source company regulatory colleagues to ensure understanding of regulatory requirements in Malaysia and request the documentation required for registration submissions.

  • Build constructive relationships with the local health authority by compiling and submitting required documents and providing prompt responses to questions.

  • Maintain an awareness of new legislation, policies and guidelines impacting the assigned product portfolio.

  • Participate in discussion groups for the industry association or discussion with HA, as required.

  • Contribute to continuous review and improvement of processes within the Malaysia Regulatory Affairs department to ensure consistent, efficient and effective practices across the team.

  • Contribute to Regulatory Affairs Team meetings to learn from colleagues, share experiences and best practice. Assist Regulatory Affairs colleagues in supporting other product portfolios or regulatory activities, as required.

  • Engage marketing to strategize new product regulatory pathways or discontinuation.

  • Support internal and external audits.

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* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.

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