Senior Regulatory Affairs Lead — Global Submissions

Placements24; Mossel Bay; Híbrido; ZAR 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

Placements24 in Mossel Bay, Western Cape seeks a Senior Pharmaceutical Regulatory Affairs Specialist to lead regulatory submissions, ensure compliance, and steer lifecycle management for products. You will collaborate across R&D, QA, and Commercial teams to align strategies with business goals, mentor junior staff, and drive timely approvals.

The role requires a Master’s degree in a relevant field and at least 6 years of regulatory experience, with CTD/eCTD expertise and familiarity with SA

Formación

• 6+ years of experience in pharmaceutical regulatory affairs.
• Experience with CTD/eCTD submissions.
• Strong knowledge of SA regulations and major international frameworks (FDA, EMA).
• Proven ability to manage lifecycle variations and post-approval activities.

Responsabilidades

• Prepare, review, and submit regulatory documentation to authorities such as SAHPRA, FDA, and EMA.
• Ensure compliance of products and processes with current regulatory requirements.
• Provide strategic regulatory guidance on development, lifecycle management, and market access.
• Manage responses to regulatory queries and requests for information.
• Conduct regulatory intelligence to monitor changes in the environment.
• Collaborate with R&D, QA, and Commercial teams to align regulatory strategy with business goals.
• Maintain regulatory databases and accurate records of submissions and approvals.
• Lead regulatory aspects of change controls and post-approval commitments.
• Support development and implementation of regulatory processes and SOPs.
• Mentor junior regulatory staff and share knowledge in Mossel Bay.

Conocimientos

Regulatory submissions

Regulatory strategy

Lifecycle management

Regulatory intelligence

Project management

Cross-functional collaboration

Educación

Master's degree in Pharmacy, Chemistry, Life Sciences

Descripción del empleo

Placements24 in Mossel Bay, Western Cape seeks a Senior Pharmaceutical Regulatory Affairs Specialist to lead regulatory submissions, ensure compliance, and steer lifecycle management for products. You will collaborate across R&D, QA, and Commercial teams to align strategies with business goals, mentor junior staff, and drive timely approvals.

The role requires a Master’s degree in a relevant field and at least 6 years of regulatory experience, with CTD/eCTD expertise and familiarity with SA