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Senior Country Approval Specialist

Thermo Fisher Scientific (Thailand)
Thermo Fisher Scientific (Thailand) (Bangkok, Bangkok City, Thailand)
Bangkok, Thailand 🇹🇭
Thermo Fisher Scientific (Thailand)
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

About this position

Thermo Fisher Scientific Inc. is looking for a Senior Country Approval Specialist to join their team in Bangkok. The role involves preparing and coordinating local regulatory submissions, developing submission strategies, and ensuring compliance with guidelines and processes.

Responsibilities

• Prepare, review and coordinate local regulatory submissions (MoH, EC, additional special national local applications if applicable) in alignment with global submission strategy
• Develops and implements local submission strategy (regulatory and ethics committees). Provides technical expertise and coordination. oversight for projects in collaboration with relevant internal departments to ensure local submission activity is planned and delivered in accordance with global project submission strategy
• Primary contact for investigators and with the local regulatory authorities (in collaboration with the local regulatory manager for complex issues) to ensure submissions are managed in a timely manner
• Collaborate with colleagues across different departments to ensure smooth implementation of research activities.
• Ensures guidelines and processes are followed for effective internal PPD team communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a timely manner
• Act as a key-contact at country level for all submission-related activities
• Participate as required in Submission Team Meetings, Review Meetings and Project Team meetings
• Coordinates with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation
• Achieves PPD’s target cycle times for site activations
• Prepare the regulatory compliance review packages, as applicable
• Liaise within SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy
• Assist with grant budgets(s) and payment schedules negotiations with sites
• Other duties as assigned

Requirements

• Bachelor's degree of medical/para-medical or scientific fields or equivalent experience
• 2 -5 years related experience or equivalent combination of education, training & experience
• Basic medical/therapeutic area and medical terminology knowledge
• Excellent knowledge of all applicable regional / national country regulatory guidelines and EC requirements
• Excellent organizational, prioritizing, planning and communication skills
• Strong attention to detail and quality of documentation
• Abil