Pharma Regulatory Affairs Specialist: Growth & Compliance

Placements24; Polokwane; Vor Ort; ZAR 600.000 - 900.000; Vollzeit

Benefits dieser Stelle

Competitive salary and annual bonus

Health, dental, and vision insurance

Generous paid time off and holidays

Retirement savings plan with company匹

Zusammenfassung

Placements24 seeks a Pharmaceutical Regulatory Affairs Specialist to join their Polokwane team, ensuring compliance with national and international regulatory standards throughout product lifecycles.

You will prepare, submit, and maintain regulatory documentation, liaise with health authorities, and guide cross-functional teams on GMP, pharmacovigilance, and CTD dossiers, with opportunities for professional growth in a forward-thinking organization.

Qualifikationen

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a 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 (e.g., CTD format).
• Strong understanding of GMP and pharmacovigilance requirements.
• Excellent written and verbal communication skills.
• Meticulous attention to detail and strong organizational skills.
• Ability to work independently and as part of a team.
• Proficiency in regulatory information management systems is a plus.
• Problem-solving skills and a proactive approach.

Aufgaben

• 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.
• Stay current with the latest regulatory guidelines and best practices.

Kenntnisse

Regulatory affairs

CTD dossiers

GMP knowledge

Pharmacovigilance

Documentation

Regulatory liaison

Communication

Detail oriented

Teamwork

Independent work

Ausbildung

Bachelor's degree in Pharmacy

Chemistry

Biology

Related scientific discipline

Tools

Regulatory information management systems

Jobbeschreibung

Placements24 seeks a Pharmaceutical Regulatory Affairs Specialist to join their Polokwane team, ensuring compliance with national and international regulatory standards throughout product lifecycles.

You will prepare, submit, and maintain regulatory documentation, liaise with health authorities, and guide cross-functional teams on GMP, pharmacovigilance, and CTD dossiers, with opportunities for professional growth in a forward-thinking organization.