Senior Regulatory Strategist - Pharma Compliance

Placements24; Vereeniging; Hybrid; ZAR 800,000 - 1,200,000; Full time

Benefits offered by this job

Competitive salary

Retirement fund

Medical aid

Job summary

Placements24 seeks a Senior Regulatory Affairs Specialist to strengthen regulatory compliance in Vereeniging, SA. You will navigate SAHPRA and ICH guidelines to ensure marketing authorization and lifecycle compliance.

The role requires a Bachelor's degree in Pharmacy or related field and at least 5 years in regulatory affairs, with strong analytical and communication skills. A broad exposure to diverse pharmaceutical products and cross-functional teams is offered.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry or related field is required.
• 5+ years progressive experience in pharmaceutical regulatory affairs.
• Experience preparing and submitting regulatory dossiers to health authorities.

Responsibilities

• Prepare, review, and submit regulatory submission dossiers to health authorities (e.g., SAHPRA).
• Liaise with health authorities to respond to queries and facilitate approvals.
• Develop and implement regulatory strategies across product lifecycle.
• Review labeling, packaging and promotional materials for compliance.
• Collaborate with R&D, QA, and Marketing on regulatory matters.

Skills

Regulatory affairs

Education

Bachelor's degree in Pharmacy

Advanced degree preferred

Job description

Placements24 seeks a Senior Regulatory Affairs Specialist to strengthen regulatory compliance in Vereeniging, SA. You will navigate SAHPRA and ICH guidelines to ensure marketing authorization and lifecycle compliance.

The role requires a Bachelor's degree in Pharmacy or related field and at least 5 years in regulatory affairs, with strong analytical and communication skills. A broad exposure to diverse pharmaceutical products and cross-functional teams is offered.