Senior Regulatory Strategist - Global Dossier & Compliance

Placements24; Sandton; Hybrid; ZAR 900,000 - 1,400,000; Full time

Benefits offered by this job

Health insurance

Retirement fund

Performance bonuses

Job summary

Placements24 is seeking a Senior Regulatory Affairs Specialist for a hybrid role in Sandton, Gauteng. You will navigate SAHPRA, FDA, and EMA requirements, lead regulatory submissions, and advise cross-functional teams on compliance across lifecycle stages.

Ideal candidates have 5+ years in regulatory affairs, strong analytical skills, and experience managing complex submissions in global markets. Hybrid work offers flexibility with in-office collaboration.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum of 5 years of progressive experience in pharmaceutical regulatory affairs.
• Proven experience in preparing and submitting regulatory submissions for various product types.

Responsibilities

• Prepare, review, and submit regulatory dossiers (CTD, ANDA, NDA) to health authorities.
• Develop and implement regulatory strategies for product registration and lifecycle management.
• Liaise with regulatory agencies (SAHPRA, FDA, EMA) and respond to queries.
• Ensure compliance with applicable regulations, guidelines, and standards for pharmaceutical products.
• Monitor changes in the regulatory landscape and assess their impact on products and operations.
• Provide regulatory guidance to cross-functional teams (R&D, manufacturing, marketing).
• Review promotional materials and labeling for regulatory compliance.
• Manage post-approval changes and variations.
• Participate in regulatory inspections and audits.

Skills

Regulatory affairs expertise

Regulatory strategy

Dossier preparation & submission

Cross-functional collaboration

Education

Bachelor's or Master's degree in Pharmacy/related field

Tools

Regulatory information management systems

Job description

Placements24 is seeking a Senior Regulatory Affairs Specialist for a hybrid role in Sandton, Gauteng. You will navigate SAHPRA, FDA, and EMA requirements, lead regulatory submissions, and advise cross-functional teams on compliance across lifecycle stages.

Ideal candidates have 5+ years in regulatory affairs, strong analytical skills, and experience managing complex submissions in global markets. Hybrid work offers flexibility with in-office collaboration.