Remote Regulatory Affairs Specialist: NDA & Variations

Placements24; LegKraal Gate; Híbrido; ZAR 600.000 - 900.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Full remote work arrangement

Health and wellness benefits

Professional development opportunities

International exposure

Generous annual leave and paid sick/ma

Descripción de la vacante

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

Formación

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

Responsabilidades

• 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.

Conocimientos

Regulatory submissions

Regulatory guidance

Remote collaboration

Educación

Bachelor's degree in Pharmacy, Chemistry, Life Sciences

Master's degree preferred

Herramientas

RIM systems

MS Office

Descripción del empleo

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