Senior Regulatory Affairs and Quality Specialist

Job Description :

Work Schedule

Environmental Conditions

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

• Ensure compliance with applicable regulatory requirements, corporate policies, and quality standards related to clinical trial supply chain operations.
• Provide regulatory and quality guidance to internal stakeholders and clients.
• Coordinate regulatory submissions and approvals, including import/export of investigational medicinal products and medical devices, clinical trial import licences, and GMP/GDP certifications.
• Act as a liaison with local and international regulatory authorities.
• Maintain regulatory licences, certificates, approvals, and related databases.
• Responsible for sourcing of comparator drugs and ancillary supplies, and management of product recalls.
• Support quality management activities including SOP maintenance, internal and external audits hosting, batch record review, in-process inspections, and CAPA management.
• Deliver QA/GMP training and support continuous improvement initiatives to enhance regulatory and quality compliance.
• Ensure data integrity compliance across relevant processes.
• Perform other duties as assigned.

REQUIREMENTS:

• Bachelor's degree in Pharmacy/related discipline Registered Pharmacist in Singapore.
• Experience in quality assurance and regulatory affairs within pharmaceutical or healthcare environments.
• Strong knowledge of quality systems, including risk management, CAPA, change control, and investigations.
• Experience with SOP development, audits, and regulatory inspections.
• Strong communication, collaboration, and documentation skills.
• Ability to work independently with strong attention to detail and problem-solving skills.