Job description

Job Title: Regulatory Affairs Manager

Location: Malaysia

Job Type: Full-Time

Industry: Pharmaceutical/Biotechnology

Job Summary: We are seeking a highly skilled and experienced Regulatory Affairs Manager to oversee the registration of pharmaceutical products in Singapore and Malaysia. The successful candidate will ensure compliance with all regulatory requirements and facilitate the timely approval of new and existing drugs.

Key Responsibilities:

• Manage the end-to-end process of drug registration in Singapore and Malaysia.
• Prepare, compile, and submit regulatory dossiers to the Health Sciences Authority (HSA) in Singapore and the National Pharmaceutical Regulatory Agency (NPRA) in Malaysia.
• Monitor and track the progress of regulatory submissions and address any queries from regulatory authorities promptly.
• Ensure compliance with local regulations, guidelines, and standards for pharmaceutical products.
• Liaise with internal teams, external partners, and regulatory bodies to ensure smooth and efficient registration processes.
• Stay updated on changes in regulatory requirements and communicate these changes to relevant stakeholders.
• Provide regulatory guidance and support to cross-functional teams, including R&D, Quality Assurance, and Marketing.
• Conduct risk assessments and develop strategies to mitigate regulatory risks.
• Maintain accurate and up-to-date records of all regulatory activities and documentation.

Qualifications:

• Bachelor’s degree in Pharmacy, Life Sciences, or a related field. A Master’s degree is preferred.
• Minimum of 5 years of experience in regulatory affairs, with a focus on drug registration in Singapore and Malaysia.
• In-depth knowledge of regulatory requirements and submission processes in both countries.
• Strong project management skills and the ability to handle multiple projects simultaneously.
• Excellent communication and interpersonal skills.
• Proficiency in English; knowledge of additional languages is a plus.
• Detail-oriented, proactive, and able to work independently.

Benefits:

• Competitive salary and performance-based bonuses.
• Comprehensive health and wellness benefits.
• Opportunities for professional development and career advancement.
• Collaborative and inclusive work environment.

Application Process: Interested candidates are invited to submit their resume and a cover letter detailing their relevant experience and qualifications.