A leading multinational pharmaceutical company is currently seeking a Head of Regulatory Affairs. In this job, you will based in Jakarta to lead their Regulatory Affairs Department in Indonesia that will report directly to the Director based out of Indonesia.
About the Head of Regulatory Affairs Role: As the Head of Regulatory Affairs, 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 the Global Director based out of Indonesia.
Lead the discussion with key stakeholder in government sector and regulatory bodies to ensure the registration of products are well executed
Be the ambassador of the company in the related association, community, or committee of the industry
Provide expert guidance for the review, development, and implementation of regulatory policies, technical standards, and industry best practices related to GMP and clinical trials
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
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
To succeed in this Head of Regulatory Affairs, you must have a leadership behaviour, growth mindset, strong technical knowledge and ready to have lead the strategic initiative to support the company's growth.
Minimum of 15 years in regulatory affairs in pharmaceutical companies
Proven success in registration of complex pharmaceutical or medical devices or related products
Strong network in the governmental sector, BPOM, and MoH with ability to negotiate and lead the discussion with key stakeholders
Strong knowledge of biopharmaceuticals and stem cell is advantageous
Familiarity with Indonesian regulations related to cell and biopharmaceuticals
Bachelor's degree or higher in pharmacy
Proficient in English and excellent communication skills
Participation in international scientific advisory committees/work groups for cell and tissue therapy
Experience preparing clinical trial and relevant documents for new product registration
Proven ability to establish positive relationships with government authorities, especially BPOM or similar institutes
This leading pharmaceuticals is well-known globally and expanding rapidly in Indonesia, joining this company means you will be part of the rewarding growth of this market leading company. It is a fast-paced environment as they are establishing a new business unit in Indonesia.
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 Head of Regulatory Affairs 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.