Pharma Regulatory Affairs Specialist for Growth & Impact

Placements24; Polokwane; Sur place; ZAR 540 000 - 900 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Health, dental, and vision insurance

Generous paid time off

Retirement savings plan with company-m

Professional development and training

Life insurance and disability benefits

Employee assistance program

Résumé du poste

Placements24 in Polokwane seeks a Pharmaceutical Regulatory Affairs Specialist to manage regulatory submissions, filings, and compliance throughout product lifecycle. You will liaise with health authorities and guide internal teams on regulatory strategy.

The ideal candidate has a pharmacy/chemistry/biology degree with at least 3 years in regulatory affairs, strong documentation discipline, and excellent communication to support product approvals and market maintenance.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology or related scientific discipline.
• Minimum of 3 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of regulatory requirements for drug approval and post-approval in relevant markets.
• Experience with preparing and submitting dossiers (CTD format).
• Strong understanding of GMP and pharmacovigilance requirements.
• Excellent written and verbal communication skills.

Responsabilités

• Prepare, review, and submit regulatory documentation for product registrations, variations, and renewals.
• Maintain regulatory filings and ensure compliance with applicable regulations.
• Liaise with regulatory agencies, health authorities, and other stakeholders.
• Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, and marketing.
• Monitor regulatory changes and assess their impact on the company's products and operations.
• Review promotional materials for regulatory compliance.
• Participate in regulatory audits and inspections.
• Contribute to the development and implementation of regulatory strategies.
• Ensure that all regulatory activities are conducted in accordance with company policies and procedures.

Connaissances

Regulatory knowledge

Documentation quality

Communication skills

Organizational skills

Team collaboration

Problem-solving

Formation

Bachelor's degree in Pharmacy/ Chemistry/ Biology

Outils

Regulatory information management systems

Description du poste

Placements24 in Polokwane seeks a Pharmaceutical Regulatory Affairs Specialist to manage regulatory submissions, filings, and compliance throughout product lifecycle. You will liaise with health authorities and guide internal teams on regulatory strategy.

The ideal candidate has a pharmacy/chemistry/biology degree with at least 3 years in regulatory affairs, strong documentation discipline, and excellent communication to support product approvals and market maintenance.