Remote Regulatory Affairs Specialist for Global Submissions

Placements24; Cape Town; Hybrid; ZAR 800.000 - 1.200.000; Vollzeit

Benefits dieser Stelle

Fully remote work

Insurance package

Professional development allowance

Zusammenfassung

Placements24 is seeking a Regulatory Affairs Specialist to join a globally distributed team in a fully remote capacity. You will ensure compliance with health authority regulations for pharmaceutical products, prepare and review regulatory documentation, and manage interactions with agencies worldwide.

The role requires 4+ years in pharmaceutical regulatory affairs, knowledge of FDA/EMA/SAHPRA, and strong communication skills to navigate the complex regulatory landscape and bring medicines to

Qualifikationen

• Minimum of 4 years of experience in pharmaceutical regulatory affairs.
• Knowledge of global regulatory requirements (FDA, EMA, SAHPRA).
• Experience with regulatory submission software and EDMS.
• Strong understanding of drug development and lifecycle management.
• Excellent written and verbal communication skills.

Aufgaben

• Prepare and submit regulatory submissions to health authorities globally.
• Review and approve product labeling and promotional materials for regulatory compliance.
• Interpret and apply global regulatory guidelines to development and lifecycle management.
• Serve as primary contact with regulatory agencies for inquiries and submissions.
• Develop regulatory strategies for new product development and post-approval activities.
• Monitor changes in the regulatory environment and assess impact on products and operations.

Kenntnisse

Regulatory affairs knowledge

Global regulatory guidelines

Communication skills

Attention to detail

Ausbildung

Bachelor's or Master's degree in a scientific, pharmaceutical, or related discipline

Tools

Regulatory submission software

Electronic document management systems

Jobbeschreibung

Placements24 is seeking a Regulatory Affairs Specialist to join a globally distributed team in a fully remote capacity. You will ensure compliance with health authority regulations for pharmaceutical products, prepare and review regulatory documentation, and manage interactions with agencies worldwide.

The role requires 4+ years in pharmaceutical regulatory affairs, knowledge of FDA/EMA/SAHPRA, and strong communication skills to navigate the complex regulatory landscape and bring medicines to