Regulatory Affairs Executive

工作内容

Rxilient Health stands as a dynamic platform specializing in the integration of pharmaceutical innovation, commercialization, and comprehensive product lifecycle management. We have successfully established our presence across SEAT markets, extending our reach to Malaysia, Thailand, Indonesia, the Philippines, Vietnam, and Taiwan.

The Role

You Will Be Responsible For

• Report directly to RA Manager and be responsible for supporting our regulatory team in ensuring compliance with local and international regulations for our pharmaceutical products.
• Assist in the preparation, review, and submission of regulatory documents, including registration dossiers, variations, and renewals, to regulatory authorities in compliance with local regulations and guidelines.
• Conduct research and gather relevant information on regulatory requirements, guidelines, and standards to ensure compliance with local and international regulations.
• Support the maintenance of regulatory databases and tracking systems for product registrations, renewals, and changes.
• Collaborate with cross-functional teams to gather necessary data and documentation for regulatory submissions.
• Assist in the preparation of regulatory strategies and plans to ensure timely and successful product registrations.
• Monitor and stay updated on changes in regulatory requirements and guidelines and communicate relevant updates to the team.
• Assist in the preparation of responses to regulatory agencies’ queries and requests for information.
• Support the review and approval process for labeling, promotional materials, and other relevant documents to ensure compliance with regulatory standards.
• Assist in the coordination and preparation of regulatory audits and inspections.
• Perform any other ad-hoc duties as and when assigned by the Company.
  
  

Ideal Profile

• Hold a Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field.
• Exhibit a strong interest and understanding of regulatory affairs in the pharmaceutical sector.
• Possess knowledge (preferred) of local and international regulatory guidelines and requirements.
• Demonstrate exceptional attention to detail, organizational skills, and proficient written and verbal communication skills.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
• Have the ability to thrive in a team-oriented and fast-paced setting.
• Proactive and self-motivated with a strong willingness to learn and contribute to the field of regulatory affairs.
• Have the capability to prioritize tasks effectively and adhere to deadlines.
  
  

What’s on Offer?

• Work in a company with a solid track record of performance
• Opportunity to make a positive impact
• Attractive Salary & Benefits