Regulatory Affairs Manager

Key Responsibilities

1. Regulatory and Compliance Duties:

• Liaison Role: Act as the primary contact with regulatory bodies for product registrations, regulatory queries, and updates. This includes handling product registrations, maintaining licenses, and overseeing registration projects.
• Product Registration: Manage the registration of Sinovac’s products in Singapore and collaborate with RAs in South-East Asia where necessary, including strategic planning for new products and handling renewals and variations.
• Regulatory Strategy: Develop and implement regulatory strategies and ensure compliance with regulations. This includes reviewing product submissions and maintaining communication with regulatory authorities. Monitor emerging trends regarding industry regulations to determine potential impact on organisational processes. Support and evaluate business development projects, including early pipeline products, from RA perspective. Well verse in Singapore and the regions’ regulatory requirements and able to support and collaborate with global team to ensure business optimisation.

2. Core Job Responsibilities:

• Registration and Compliance: Coordinate new product submissions, handle regulatory approvals, and manage compliance with local and regional regulations. Ensure that marketing applications, product variations and change notifications are processed in a timely manner. Plan and coordinate regulatory and classification body audits with relevant authorities, prepare auditees and relevant documentations prior to audits and handle audit follow-ups with both internal stakeholders and regulatory authorities.
• Internal Processes and Improvement: Review and harmonize regulatory processes across different regions, manage documentation, and streamline procedures to enhance productivity.
• People Management: Where appropriate, lead and mentor the RA team, set goals, and manage performance. Develop succession plans and ensure the team meets critical objectives.
• Business Support: Provide regulatory input and support for marketing plans, product launches, and handle internal and external inquiries. Monitor registration status and provide updates to management. This includes working with distributors to provide regulatory support as well.
• Cross functional: Work collaboratively with cross-functional team to ensure regulatory compliance and market continuity.

3. Processes:

• Documentation and Systems: Ensure proper filing of documentation, manage artwork and label changes, and maintain regulatory databases. Develop and review the regulatory budget and handle product recalls and complaints.
• Compliance and SOPs: Ensure adherence to internal SOPs and regulatory standards. Regularly review and update local and regional procedures to maintain compliance.

4. Regulatory Intelligence:

• Knowledge and Updates: Stay informed about changes in regulations affecting registration and product compliance. Assess the impact of regulatory changes on the company’s operations.

Qualifications

1. Educational Background: Bachelor’s Degree in Pharmacy or Pharmaceutical Science.
2. Registered pharmacist with Singapore Pharmacy Council
3. Experience: 5-7 years of regulatory experience in the pharmaceutical or medical device industry, with a strong understanding of Singaporean and regional regulations.
4. Skills:

• Communication: Excellent oral and written communication skills in English and Chinese.
• Leadership: Strong management and interpersonal skills with the ability to influence and lead teams effectively.
• Analytical Abilities: Proficient in strategic thinking, problem-solving, and multitasking under pressure.
• Work Ethic: Demonstrated commitment to achieving excellence and meeting deadlines.