Senior Medical Writer: Global Regulatory Submissions

Placements24; Stellenbosch; On-site; ZAR 1,000,000 - 1,500,000; Full time

Benefits offered by this job

Competitive salary

Medical, dental, and vision insurance

Relocation assistance

Professional development opportunities

Job summary

Placements24 seeks a Senior Medical Writer for its regulatory affairs department in Stellenbosch, Western Cape. The role focuses on planning, writing, editing, and reviewing regulatory documents essential for drug approval and post-marketing activities.

The candidate will collaborate with R&D, clinical, and regulatory teams to ensure accuracy, clarity, and compliance with global standards. Leadership and mentoring duties are included.

Qualifications

• Master's degree or Ph.D. in a Life Science, Pharmacy, or related discipline.
• Minimum of 5 years of experience in medical writing within pharma/biotech.
• Proven track record of authoring complex regulatory documents for global submissions.
• Understanding of drug development and global regulatory requirements (US, EU).
• Exceptional written and verbal communication, detail-oriented.

Responsibilities

• Author, edit, and review regulatory submission documents (INDs, NDAs, CTDs, PSURs).
• Ensure scientific accuracy and regulatory compliance across guidelines (ICH, FDA, EMA).
• Collaborate with SMEs to gather content and ensure accuracy.
• Manage document timelines and project plans to meet deadlines.
• Mentor junior medical writers and contribute to templates, style guides, and SOPs.

Skills

Regulatory submissions

Document management

Cross-functional collaboration

Education

Master's degree or PhD in Life Science/Pharmacy

Tools

Regulatory submission software

Document management systems

Job description

Placements24 seeks a Senior Medical Writer for its regulatory affairs department in Stellenbosch, Western Cape. The role focuses on planning, writing, editing, and reviewing regulatory documents essential for drug approval and post-marketing activities.

The candidate will collaborate with R&D, clinical, and regulatory teams to ensure accuracy, clarity, and compliance with global standards. Leadership and mentoring duties are included.