Senior Regulatory Affairs Specialist

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November 21

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Thermo Fisher Scientific

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Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

📋 Description

• Provide regulatory advice and carry out projects in the provision of regulatory affairs services whilst acting as liaison with internal and external clients • Act as a representative of the regulatory department in Argentina with other departments, supporting business development, working on initiatives, and contributing to quality improvement • Preparation and assembly of local regulatory submissions in Argentina based on each case • Interact with sponsors, review and assess clinical trial regulatory documents, review and assess scientific literature • Participate in launch meetings, review meetings and project team meetings

🎯 Requirements

• 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 • Knowledge of the local clinical trials landscape • Good command of the English language (written and oral) as well as local language • 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 • Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies • Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects • Excellent understanding of national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines • Excellent analytical, investigative and problem-solving skills

🏖️ Benefits

• 25 days annual leave • Private healthcare • Pension scheme • Flexible working hours • Professional development opportunities