Regulatory Affairs Manager

Title: Regulatory Affairs Manager

Location: Singapore and Malaysia

Duration: 6 months

CAP 155 hours per month

Company Overview

Apsida Life Science is partnering with an organisation dedicated to community-based clinical trials, ensuring excellent participant care and a smooth transition from hospital to home in accordance with study protocols, clinical practice regulations, and ICH-GCP requirements.

Responsibilities:

• Ensure oversight on key processes and ensure framework is in place to manage third-party activities E2E ensuring compliance with regulations and company standards; monitor partner performance against agreed-upon metrics and standards, addressing any deviations or deficiencies promptly
• Conduct periodic assessments of partners to ensure compliance with local requirements and quality standards, implementing corrective actions as necessary; develop risk mitigation strategies and implement controls to minimize risks associated with partner activities
• Stay updated on local regulatory requirements, guidelines, and industry trends to ensure compliance with evolving regulations and communicate to GRA and local team; participating in policy activities with industry groups and trade associations
• Support regional regulatory TA teams within GRA, for efficient planning and submission preparation according to local requirements and business needs
• Monitor training effectiveness and compliance, ensure proper trainings are developed and in place, providing support and resources as needed to address gaps and improve performance

Qualifications:

• Ideally 5+ years of experience in Rrgulatory Affairs , oversight, governance or compliance roles within pharmaceutical, biotechnology or healthcare industry
• Partner management experience: proven experience in managing relationships with third-party vendors,
• Ability to work in a highly matrixed organization and to establish successful cross-functional working relationships with people in a wide variety of disciplines and backgrounds, be interpersonally aware and culturally sensitive
• Fluent in local language, English, oral and written

If you are interested in learning more or wish to apply, please reach out to Sweetness Zono at Apsida Life Science: Email: [Confidential Information] Website: www.apsida.co.uk

Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa), dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective, high-quality, and trusted recruitment service that puts the candidate journey at the heart of the recruitment process