Senior Regulatory Affairs Executive

Job Title: Senior Regulatory Affairs Executive

Location: Singapore

Job Type: Full-Time

Our client is a dynamic and innovative pharmaceutical company, dedicated to improving patient outcomes through cutting-edge research and development. They are committed to maintaining the highest standards of regulatory compliance and ensuring the safety and efficacy of our products.

Job Responsibilities:

• Regulatory Strategy: Develop and implement regulatory strategies to ensure timely approval of new products and maintenance of existing product licenses.
• Submission Management: Prepare, review, and submit regulatory documents to health authorities, including the Health Sciences Authority (HSA) in Singapore.
• Compliance: Ensure compliance with local and international regulatory requirements, guidelines, and standards.
• Liaison: Act as the primary point of contact with regulatory agencies, responding to queries and providing necessary documentation.
• Cross-Functional Collaboration: Work closely with R&D, Quality Assurance, and Marketing teams to ensure regulatory requirements are met throughout the product lifecycle.
• Regulatory Intelligence: Stay updated on regulatory changes and trends, and provide guidance to internal teams on potential impacts.
• Training: Provide training and support to junior regulatory staff and other departments on regulatory affairs processes and requirements.

Qualifications:

• Education: Bachelor's degree in Pharmacy, Life Sciences, or a related field. Advanced degree preferred.
• Experience: Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry.
• Knowledge: In-depth knowledge of local and international regulatory requirements, including ICH guidelines and ASEAN regulations.
• Skills: Excellent communication, organizational, and project management skills. Ability to work independently and as part of a team.
• Attention to Detail: Strong attention to detail and ability to manage multiple projects simultaneously.