job description
Join Hyphens Pharma, a leading name in the healthcare and pharmaceutical industry, as a Regulatory Affairs Executive in the vibrant heart of Bali. This is a unique opportunity to play a pivotal role in ensuring compliance, product registration, and regulatory excellence in a dynamic and fast-paced environment.
As a Regulatory Affairs Executive, you will be at the forefront of liaising with health authorities, managing regulatory submissions, and maintaining up-to-date knowledge of local and international regulations. Your expertise will drive the successful approval and market access of our life-changing pharmaceutical products, contributing to the health and well-being of communities across the region.
Based in Kuta, Badung, you’ll enjoy a collaborative work culture, professional growth opportunities, and the chance to make a tangible impact in the healthcare sector. If you are a detail-oriented professional with a passion for regulatory compliance and a desire to thrive in a global pharmaceutical company, we invite you to apply and be part of our mission to deliver excellence in healthcare.
Responsibility
- Oversee and manage the product registration process with local and international health authorities, ensuring timely submissions and approvals.
- Liaise with regulatory agencies, including NPRA (National Pharmaceutical Regulatory Agency) and other relevant bodies, to facilitate compliance and resolve queries.
- Maintain and update regulatory databases and documentation systems to ensure accuracy, completeness, and accessibility.
- Monitor and interpret new and evolving regulations, assessing their impact on the company’s products and operations.
- Prepare and review regulatory dossiers, including technical files, labeling, and promotional materials, in accordance with applicable guidelines.
- Collaborate with cross-functional teams, including R&D, Quality Assurance, and Marketing, to ensure regulatory compliance throughout the product lifecycle.
- Provide regulatory training and guidance to internal stakeholders to enhance awareness and adherence to compliance standards.
- Represent the company in industry forums, workshops, and regulatory meetings to stay abreast of best practices and emerging trends.
Qualifications
- A Bachelor’s degree in Pharmacy, Life Sciences, or a related field. A Master’s degree or additional certifications in Regulatory Affairs is a plus.
- Minimum 3-5 years of experience in regulatory affairs, preferably within the pharmaceutical or healthcare industry.
- In-depth knowledge of local and international regulatory requirements, including ASEAN guidelines, ICH, and GMP standards.
- Proven experience in product registration, dossier preparation, and submission processes with health authorities.
- Strong analytical, communication, and negotiation skills with the ability to interact effectively with regulatory bodies and internal teams.
- Proficiency in regulatory software and database management tools (e.g., Veeva, TrackWise).
- High attention to detail with a problem-solving mindset and the ability to work under tight deadlines.
- Fluency in English (written and spoken); knowledge of Bahasa Indonesia or other ASEAN languages is advantageous.