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Sylvie Heri

Sylvie Heri

Biotechnology and biochemistry graduate transitioning into Regulatory Affairs, open to remote & international roles

Talent
Johannesburg Metropolitan AreaMember since May 14, 2026
Regulatory documentation & scientific writingKnowledge of FDA, EMA, ICH guidelinesCTD/eCTD structureSOP compliance & quality standards (GLP/GMP awareness)Data integrity & traceabilityLiterature review & regulatory intelligenceCross-functional collaborationMicrosoft Office & Google Workspace
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Regulatory documentation & scientific writingKnowledge of FDA, EMA, ICH guidelinesCTD/eCTD structureSOP compliance & quality standards (GLP/GMP awareness)Data integrity & traceability

About

Biotechnology and biochemistry graduate transitioning into Regulatory Affairs, with strong experience in laboratory operations, scientific documentation, and compliance-driven environments. Skilled in data integrity, SOP adherence, and technical writing, with working knowledge of global regulatory frameworks (FDA, EMA, ICH). Currently training in drug approval processes and global submissions.

Detail-oriented and highly analytical, seeking an entry-level Regulatory Affairs role (remote or on-site).

Experience

Freelance Scientific Writing & Translation at Freelance (2023-01 – Present)

  • Prepare, edit, and proofread scientific and technical documents
  • Translate technical content between English and French with high accuracy
  • Support structured documentation aligned with scientific and regulatory standards

Junior Researcher at Institute for the Development of Energy for Africa Sustainability (IDEAS) (2019-06 – 2022-11)

  • Conducted laboratory-based research in biotechnology and microbiology under structured protocols
  • Designed and executed experimental procedures in compliance with established SOPs
  • Maintained accurate and traceable laboratory records ensuring data integrity and reproducibility
  • Contributed to scientific publications and technical reports aligned with documentation standards
  • Collaborated with multidisciplinary teams, ensuring clear communication of scientific findings

Laboratory & Teaching Assistant at University of Johannesburg (2015-06 – 2017-11)

  • Supervised laboratory practical sessions ensuring adherence to safety and procedural guidelines
  • Prepared reagents and materials in compliance with laboratory quality standards
  • Supported quality assessment of laboratory reports with focus on accuracy and completeness
  • Reinforced best practices in documentation and experimental procedures among students

Education

Regulatory affairs certification – Udemy

Master of Engineering in Biotechnology – University of South Africa

BSc Honours in Biochemistry – University of Johannesburg

BSc in Biochemistry & Human Physiology – University of Johannesburg

Skills

open to remote & international roles

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