Pharma Regulatory Affairs Specialist - Growth & Compliance

Placements24

Stellenbosch

On-site

ZAR 700,000 - 1,000,000

Full time

14 days+

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Benefits offered by this job

Health, dental, and vision insurance

Retirement fund and benefits

Professional development opportunities

Collaborative compliance-focused team

Job summary

Placements24 seeks a Regulatory Affairs Specialist in Stellenbosch to ensure pharmaceutical products comply with national and international regulations throughout development to post-market. You will prepare regulatory documentation, liaise with health authorities, and monitor evolving regulations to support market access and ongoing compliance.

The role requires a Bachelor’s degree in a relevant field and a minimum of 4 years in regulatory affairs, with strong SAHPRA experience and CTD dossier

Qualifications

Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or related.
Minimum 4 years in regulatory affairs within pharma.
Strong understanding of South African and international regulations.

Responsibilities

Prepare, review, and submit regulatory documentation to SAHPRA and other authorities.
Ensure submissions comply with GMP/GCP and applicable regs.
Serve as main regulatory contact with agencies; respond to queries.
Monitor regulatory changes and assess impact on products and ops.
Develop regulatory strategies to support development and lifecycle management.
Maintain regulatory databases and archives with accurate documentation.

Skills

Regulatory submissions

GMP/GCP knowledge

Stakeholder communication

Regulatory strategy

Education

Bachelor's in Pharmacy/ Chemistry/ Life Sciences

Tools

CTD format

Job description

The role requires a Bachelor’s degree in a relevant field and a minimum of 4 years in regulatory affairs, with strong SAHPRA experience and CTD dossier

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