Senior Regulatory Affairs Specialist — Global Submissions & Strategy

Placements24; Benoni; Ibrido; ZAR 900.000 - 1.500.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

Pension plan

Paid time off

Professional growth

Descrizione del lavoro

Placements24 in Benoni, Gauteng seeks a Senior Regulatory Affairs Specialist to guide regulatory strategy and ensure compliance across SA, Europe, and the US. You will prepare, submit, and manage regulatory dossiers, interact with health authorities, and lead cross-functional teams through product lifecycle.

The ideal candidate holds a life sciences degree, 5+ years in regulatory affairs, CTD experience, and strong communication. Fluency in English is essential.

Competenze

• Bachelor's degree in Pharmacy, Chemistry, Biology or related life science.
• Master's degree or equivalent experience preferred.
• Minimum of 5 years in pharmaceutical regulatory affairs; CTD experience.

Mansioni

• Prepare, review, and submit regulatory dossiers for NDAs, variations, and renewals.
• Develop regulatory strategies for product development and lifecycle management.
• Liaise with SAHPRA, FDA, EMA and other authorities; respond to queries.
• Ensure compliance with regulations, guidelines, and company policies.
• Provide regulatory guidance to R&D, manufacturing, and marketing teams.
• Monitor regulatory environment changes and their impact on products.
• Maintain regulatory documents and participate in inspections and audits.
• Manage post-approval commitments and variations.
• Contribute to regulatory SOPs and best practices.

Conoscenze

Analytical skills

Problem-solving

Critical thinking

Written communication

Verbal communication

Regulatory information management

Independent work

Multitasking

Formazione

Bachelor's degree in Pharmacy/ Chemistry/ Biology or related life science

Master's degree or equivalent experience

Strumenti

CTD knowledge

Regulatory databases

Descrizione del lavoro

Placements24 in Benoni, Gauteng seeks a Senior Regulatory Affairs Specialist to guide regulatory strategy and ensure compliance across SA, Europe, and the US. You will prepare, submit, and manage regulatory dossiers, interact with health authorities, and lead cross-functional teams through product lifecycle.

The ideal candidate holds a life sciences degree, 5+ years in regulatory affairs, CTD experience, and strong communication. Fluency in English is essential.