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Regulatory Affairs Manager

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

We are currently seeking a Regulatory Affairs Manager to join our global Regulatory Affairs department. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting.

Responsibilities

• Lead the preparation of global regulatory submissions and ensure high quality standards that meet local and regional requirements.
• Act as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and for key client projects of moderate to high complexity.
• Provides internal clients with up-to-date legislation and guidance as it becomes available.
• Ensure quality performance for key/managed projects.
• Manage project budgeting/forecasting functions.
• Identify and recognize out of scope activities in a contract in a timely manner and liaise with other departments to follow through on all aspects of contract modifications.
• Collaborate with business development in pricing and securing new business by making presentations to clients and developing proposal texts and budget in collaboration with other departments.
• Provides matrix/project leadership, training and guidance to junior team members.
• Ensure compliance with relevant organizational and regulatory SOPs and WPDs.
• Participate in launch meetings, review meetings and project team meetings.

Requirements

• What the role requires you to have: Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job, at least 5 years.
• Proven project management experience, and experience performing effectively in a client facing role.
• Excellent English language (written and oral) communication skills as well as local language where applicable.
• Excellent attention to detail and quality as well as excellent editorial/proofreading skills.
• Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments.