Remote Regulatory Affairs Specialist: NDA & Variations

Placements24; LegKraal Gate; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Full remote work arrangement

Health and wellness benefits

Professional development opportunities

International exposure

Generous annual leave and paid sick/ma

Job summary

Placements24 is seeking a Regulatory Affairs Specialist for a fully remote role based in Mahikeng, North West, ZA. You will prepare, submit, and maintain regulatory filings for NDAs and variations across global markets, ensuring compliance with ICH, FDA, EMA, and SAHPRA guidelines.

Responsibilities include liaising with health authorities, tracking submission timelines, developing regulatory strategies, reviewing labeling and promotional materials, and providing guidance to R&D and marketing

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences or related field.
• Masters degree or equivalent preferred.

Responsibilities

• Prepare, submit, and maintain regulatory filings (NDAs, variations) globally.
• Ensure compliance with ICH, FDA, EMA, SAHPRA guidelines.
• Liaise with health authorities and respond to queries.
• Track submission timelines and manage regulatory commitments.
• Develop regulatory strategies to support product development.

Skills

Regulatory submissions

Regulatory guidance

Remote collaboration

Education

Bachelor's degree in Pharmacy, Chemistry, Life Sciences

Master's degree preferred

Tools

RIM systems

MS Office

Job description

Placements24 is seeking a Regulatory Affairs Specialist for a fully remote role based in Mahikeng, North West, ZA. You will prepare, submit, and maintain regulatory filings for NDAs and variations across global markets, ensuring compliance with ICH, FDA, EMA, and SAHPRA guidelines.

Responsibilities include liaising with health authorities, tracking submission timelines, developing regulatory strategies, reviewing labeling and promotional materials, and providing guidance to R&D and marketing