Remote Senior Regulatory Affairs Strategist

Placements24; Stellenbosch; Hybrid; ZAR 2,300,000 - 3,122,000; Full time

Benefits offered by this job

Fully remote work arrangement with Aut

Highly competitive annual salary and a

Comprehensive executive-level health &

Generous vacation policy and travel

Professional development budget

Dynamic and forward-thinking culture

Job summary

Placements24 is seeking a highly experienced Senior Regulatory Affairs Specialist to lead regulatory strategies for global pharma programs. This fully remote role offers strategic influence across markets and a path to shape development timelines.

The successful candidate will master submissions to SAHPRA, FDA, and EMA, oversee post-market activities, mentor staff, and ensure compliance with ICH, GCP, GMP guidelines while driving efficient, ethical approvals.

Qualifications

• 7+ years progressive experience in pharmaceutical regulatory affairs.
• Proven track record of successful regulatory submissions in major markets.
• Excellent remote collaboration and communication skills.

Responsibilities

• Develop and implement global regulatory strategies for new drug applications and submissions.
• Prepare, review, and submit regulatory documents to SAHPRA, FDA, and EMA.
• Liaise directly with regulatory agencies to address queries and facilitate the approval process.
• Maintain up-to-date knowledge of evolving regulatory requirements and advise the organization accordingly.
• Oversee post-market regulatory activities, including variations, renewals, and compliance reporting.
• Mentor junior regulatory affairs personnel and contribute to the development of departmental processes and best practices.

Skills

Strategic thinking

Regulatory strategy

Project management

Remote collaboration

Communication skills

ICH/GCP/GMP knowledge

Education

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

Job description

Placements24 is seeking a highly experienced Senior Regulatory Affairs Specialist to lead regulatory strategies for global pharma programs. This fully remote role offers strategic influence across markets and a path to shape development timelines.

The successful candidate will master submissions to SAHPRA, FDA, and EMA, oversee post-market activities, mentor staff, and ensure compliance with ICH, GCP, GMP guidelines while driving efficient, ethical approvals.