Remote Senior Regulatory Affairs Strategist – Pharma

Placements24; United States; Remote; USD 54.000 - 78.000; Vollzeit

Benefits dieser Stelle

Home office stipend

Health insurance

Retirement savings plan

Professional development

Zusammenfassung

Placements24 is seeking a Senior Regulatory Affairs Specialist to join a dynamic pharmaceutical manufacturer in a remote capacity, primarily serving Welkom, Free State, and beyond. You will prepare CTD dossiers, liaise with SAHPRA and other authorities, and shape regulatory strategies across development and lifecycle management.

The ideal candidate has 6+ years in regulatory affairs, strong analytical skills, and excellent communication.

Qualifikationen

• Bachelor's degree in Pharmacy, Chemistry, Biology or related field.
• Minimum of 6 years in pharmaceutical regulatory affairs.
• Knowledge of SAHPRA and ICH guidelines.
• Experience in preparing and submitting registration dossiers.
• Strong analytical skills and attention to detail.
• Excellent written and verbal communication skills.
• Ability to work independently in a remote setting.
• Proficient with RIM systems and MS Office.
• Experience navigating regulatory landscapes for Welkom markets.

Aufgaben

• Prepare, review, and submit regulatory dossiers for registrations and variations (CTD).
• Liaise with SAHPRA and other authorities; address queries and deficiencies.
• Monitor regulatory changes and assess impact on products and operations.
• Develop regulatory strategies to support development and lifecycle management.
• Review labeling, packaging, and promotional materials for compliance.
• Provide regulatory guidance to R&D, marketing, and manufacturing.
• Maintain regulatory databases and records; manage renewals and changes.
• Ensure submissions meet high regulatory standards for Welkom and beyond.

Kenntnisse

Analytical skills

Excellent communication

Regulatory strategy

Ausbildung

Bachelor's degree in Pharmacy, Chemistry, or Biology

Master's degree or equivalent

Tools

RIM systems

MS Office Suite

Jobbeschreibung

Placements24 is seeking a Senior Regulatory Affairs Specialist to join a dynamic pharmaceutical manufacturer in a remote capacity, primarily serving Welkom, Free State, and beyond. You will prepare CTD dossiers, liaise with SAHPRA and other authorities, and shape regulatory strategies across development and lifecycle management.

The ideal candidate has 6+ years in regulatory affairs, strong analytical skills, and excellent communication.