Regulatory Affairs Manager Jobs

A leading multinational pharmaceutical company is currently recruiting for a Regulatory Affairs Manager job based in Jakarta to lead their Regulatory Affairs Department in Indonesia.

About The Regulatory Affairs Manager Role

As a Regulatory Affairs Manager, you will play a pivotal role in ensuring regulatory compliance and strategic direction for Biology Products - Cell and Tissue Therapy Products in this leading global pharmaceuticals company. This role reports to Global Director based out of Indonesia.

Key Responsibilities

• Provide expert guidance for the review, development, and implementation of regulatory policies, technical standards, and industry best practices related to GMP and clinical trials of Cell and Tissue Therapy Products
• Serve as a technical expert, representing the company at regional and international meetings to influence strategic directions and desired outcomes
• Develop, standardise, execute, and approve regulatory documentation for assigned product portfolio, ensuring compliance with Indonesian regulatory bodies
• Analyse emerging developments to provide strategic and scientific insights, ensuring the regulatory framework remains adaptive and responsive
• Lead discussions and provide advice to stakeholders on efficient pre-clinical, quality, and clinical development, supporting local product registration efforts

To succeed in this Regulatory Affairs Manager role, you must have a leadership behaviour, growth mindset, strong technical knowledge and ready to have a regional experience with across jurisdiction.

Key Requirements

• Strong knowledge of biopharmaceuticals and Cell and Gene therapy regulations, including key markets (US, EU, Japan, South Korea)
• Participation in international scientific advisory committees/workgroups for Cell and Tissue Therapy
• Proven ability to establish positive relationships with government authorities, especially BPOM or similar institutes
• Bachelor's degree or higher in Pharmacy/Biology or related field
• Experience preparing INDs and NDAs, and related amendments and supplements in Indonesia
• At least six years in regulatory consulting or similar roles in biopharmaceuticals and/or Cell and Gene therapy (stem cell)
• Proficient in English and excellent communication skills
• Familiarity with Indonesian regulations related to cell and biopharmaceuticals

This leading pharmaceuticals Company needs no introduction and is recognised as the leader in the pharmaceutical industry. The culture is demanding, but if you are confident and have a can-do attitude, the potential rewards are significant. The company is also very focused on developing and training their people to the highest standards.

If you are driven, determined and want to take the next step in your career, this is the role for you. Great career progression opportunities await the right person in this exciting Regulatory Affairs Manager role.

Apply today or contact me to discuss this new opportunity.

Due to the high volume of applications we are experiencing, our team will only be in touch with you if your application is shortlisted.