Senior Regulatory Affairs Manager - Pharma (Hybrid)

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

Benefits offered by this job

Medical aid

Provident fund

Performance bonuses

Job summary

Placements24 is seeking a Senior Pharmaceutical Regulatory Affairs Manager for our Port Elizabeth, Eastern Cape client. The role leads regulatory strategy, submissions, and lifecycle management across SAHPRA, FDA, and EMA.

A strong leadership track record and expert knowledge of global regulations are required. The position offers hybrid work with office presence in Port Elizabeth and flexible remote options, along with a competitive benefits package and career development opportunities in a

Qualifications

• Bachelor’s degree in Pharmacy, Life Sciences, Chemistry or related field; Master’s preferred.
• 7+ years in pharmaceutical regulatory affairs with leadership experience.
• Strong knowledge of SAHPRA, FDA and EMA submission requirements.
• Proven track record in obtaining product registrations and approvals.

Responsibilities

• Develop and execute regulatory strategies for new and existing products.
• Prepare and submit CTD dossiers to SAHPRA, FDA and EMA.
• Engage with regulatory authorities to resolve queries and enable approvals.
• Manage post-approval activities including renewals and variations.
• Provide regulatory guidance to R&D, manufacturing, and marketing teams.
• Lead and mentor the regulatory affairs team.

Skills

Regulatory leadership

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Communication skills

Project management

GCP/GMP/GVP knowledge

Education

Bachelor’s degree in Pharmacy or Life Sciences

Master’s degree preferred

Job description

Placements24 is seeking a Senior Pharmaceutical Regulatory Affairs Manager for our Port Elizabeth, Eastern Cape client. The role leads regulatory strategy, submissions, and lifecycle management across SAHPRA, FDA, and EMA.

A strong leadership track record and expert knowledge of global regulations are required. The position offers hybrid work with office presence in Port Elizabeth and flexible remote options, along with a competitive benefits package and career development opportunities in a