Global Regulatory Affairs Lead – Hybrid Submissions

Placements24; Vereeniging; Hybrid; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

Retirement savings with company match

Generous paid time off

Hybrid work model

Professional development opportunities

Conferences participation

Job summary

Placements24 is recruiting a Senior Regulatory Affairs Specialist to lead regulatory submissions and ensure compliance for a portfolio of drug products in a hybrid Vereeniging-based role. You will strategize regulatory plans, prepare CTD/eCTD dossiers, liaise with authorities worldwide, and guide cross-functional teams across development, manufacturing, and marketing.

This position offers a balanced mix of office-based strategy and remote administration, with opportunities to influence lifecycle

Qualifications

• Bachelor's degree in a relevant field; advanced degree preferred.
• Minimum of 6 years in regulatory affairs within pharma.
• Experience preparing CTD/eCTD submissions for major markets.
• Strong knowledge of development, manufacturing, QA principles.
• Ability to interpret complex regulatory guidelines and manage timelines.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

• Develop regulatory strategies for NDAs, variations, and renewals.
• Prepare and submit regulatory dossiers (CTD/eCTD) to health authorities worldwide.
• Liaise with regulatory agencies, respond to queries, and manage reviews.
• Monitor evolving global regulatory requirements and guidelines.
• Provide regulatory guidance to R&D, manufacturing, and marketing.
• Assess proposed product changes and labeling updates.
• Manage post-approval commitments and lifecycle activities.
• Contribute to SOP development and maintenance.
• Ensure compliance with local and international regulations.
• Engage in regulatory intelligence and competitor analysis.

Skills

Regulatory submissions (CTD/eCTD)

Project management

Regulatory knowledge

Communication skills

Negotiation skills

Education

Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or related field

Advanced degree preferred

Job description

Placements24 is recruiting a Senior Regulatory Affairs Specialist to lead regulatory submissions and ensure compliance for a portfolio of drug products in a hybrid Vereeniging-based role. You will strategize regulatory plans, prepare CTD/eCTD dossiers, liaise with authorities worldwide, and guide cross-functional teams across development, manufacturing, and marketing.

This position offers a balanced mix of office-based strategy and remote administration, with opportunities to influence lifecycle