Pharmaceutical Regulatory Affairs Specialist

Placements24; Pretoria; Sur place; ZAR 600 000 - 900 000; Plein temps

Avantages offerts par ce poste

Medical aid and retirement fund

Competitive salary

Generous annual leave

Professional development opportunities

Dynamic work environment

Résumé du poste

Placements24 seeks an experienced Regulatory Affairs Specialist to join a pharmaceutical team in Centurion, Gauteng. The role focuses on ensuring compliance with local and international regulations, preparing regulatory dossiers, and engaging with health authorities to support product approvals and lifecycle management.

The ideal candidate will have a Pharmacy/Science background and at least four years of regulatory affairs experience, with strong attention to detail and ability to meet tight

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum 4 years of regulatory affairs experience in pharma.
• Experience preparing regulatory dossiers for SAHPRA and international markets.
• Knowledge of ICH guidelines and submission processes.

Responsabilités

• Prepare and submit regulatory dossiers and applications for new drug registrations, variations, and renewals.
• Ensure compliance with local and international regulatory requirements and guidelines.
• Liaise with regulatory authorities (e.g., SAHPRA) to address queries and facilitate approvals.
• Develop regulatory strategies for product lifecycle management.
• Maintain up-to-date knowledge of evolving regulatory landscapes and communicate changes to stakeholders.
• Provide regulatory support to R&D, manufacturing, and quality assurance.

Connaissances

Analytical skills

Organizational skills

Communication skills

Formation

Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or related field

Description du poste

Regulatory Affairs Specialist - Pharmaceutical Compliance

About the Role Our client, a respected pharmaceutical organization, is seeking an experienced Regulatory Affairs Specialist to join their dedicated team in Centurion, Gauteng. This pivotal role ensures that all our pharmaceutical products meet stringent local and international regulatory standards. You will be responsible for preparing and submitting regulatory dossiers, liaising with health authorities, and staying current with evolving regulations. The ideal candidate will possess a strong understanding of the pharmaceutical industry's regulatory landscape and a meticulous approach to compliance. This is an exciting opportunity to contribute to the success of a company committed to delivering high-quality healthcare solutions. We offer a supportive and professional environment in Centurion, Gauteng, encouraging professional growth and adherence to the highest ethical standards. Your expertise will be crucial in navigating the complex regulatory pathways required for product approval and maintenance.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers and applications for new drug registrations, variations, and renewals.
• Ensure compliance with all relevant local and international regulatory requirements and guidelines.
• Liaise with regulatory authorities (e.g., SAHPRA) to address queries and facilitate the approval process.
• Develop and implement regulatory strategies for product lifecycle management.
• Maintain an up-to-date knowledge of evolving regulatory landscapes and communicate changes to relevant stakeholders.
• Provide regulatory support and guidance to internal teams, including R&D, manufacturing, and quality assurance.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum of 4 years of experience in regulatory affairs within the pharmaceutical industry.
• Proven track record in preparing and submitting regulatory applications for South African and potentially other international markets.
• In-depth knowledge of pharmaceutical regulations, guidelines (e.g., ICH), and submission processes.
• Strong analytical, organizational, and communication skills.
• Ability to manage multiple submissions simultaneously and meet strict deadlines.

Benefits

• Attractive annual salary with performance-related incentives.
• Comprehensive medical aid and retirement fund contributions.
• Generous annual leave allowance.
• Opportunities for professional development and attending regulatory affairs conferences.
• A dynamic work environment in a key administrative and economic hub.