Pharmaceutical Regulatory Affairs Specialist

Placements24; George; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Retirement plan

Annual leave

Professional development

Collaborative culture

Job summary

Placements24 is seeking a Pharmaceutical Regulatory Affairs Specialist to join our client in George, Western Cape. You will prepare and submit regulatory documentation, liaise with SAHPRA and other authorities, and guide regulatory compliance across the product lifecycle.

The role requires a degree in Pharmacy, Chemistry, Life Sciences, and a minimum of 4 years in regulatory affairs, with strong communication and attention to detail. Join a collaborative team in a key South African hub.

Qualifications

• Degree in Pharmacy, Chemistry, Life Sciences or related field.
• Minimum of 4 years experience in pharmaceutical regulatory affairs.
• Experience with regulatory submissions and SAHPRA guidelines/processes.
• Familiarity with ICH, FDA, EMA is advantageous.
• Excellent written and verbal communication, detail-oriented.

Responsibilities

• Prepare, review and submit regulatory dossiers (CTD format) to SAHPRA for new drug applications and variations.
• Maintain and update product registrations for ongoing compliance.
• Monitor regulatory changes and assess impact on products and operations.
• Serve as primary contact with regulatory authorities, respond to queries and manage inspections.
• Provide regulatory strategy input for development and lifecycle management.
• Coordinate with R&D, QA and Marketing to ensure internal compliance.

Skills

Regulatory submissions

Regulatory affairs

Communication skills

Attention to detail

Education

Degree in Pharmacy, Chemistry, Life Sciences

Job description

About the Role

Our client is looking for a dedicated and knowledgeable Pharmaceutical Regulatory Affairs Specialist to join their team in George . This role is pivotal in ensuring that all pharmaceutical products meet the stringent regulatory requirements set forth by health authorities. You will be responsible for preparing and submitting regulatory documentation, liaising with regulatory bodies, and providing strategic guidance on regulatory compliance throughout the product lifecycle. This is an excellent opportunity to contribute to market access and compliance for innovative pharmaceutical products within a supportive and professional environment, working collaboratively with cross-functional teams in a key South African hub.

Key Responsibilities

• Prepare, review, and submit regulatory submission dossiers (e.g., CTD format) to regulatory agencies, including SAHPRA , for new drug applications and variations.
• Maintain and update existing product registrations, ensuring ongoing compliance with relevant regulations and guidelines.
• Monitor changes in the regulatory landscape and assess their impact on the company's products and operations.
• Act as a primary point of contact with regulatory authorities, responding to queries and managing inspections effectively.
• Provide regulatory strategy input for product development and lifecycle management.
• Ensure internal compliance by coordinating with various departments, including R&D, Quality Assurance, and Marketing.

Requirements

• Degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs.
• Demonstrated experience with regulatory submissions and a thorough understanding of SAHPRA guidelines and processes.
• Familiarity with international regulatory requirements (e.g., ICH, FDA, EMA) is advantageous.
• Excellent written and verbal communication skills, with strong attention to detail in documentation.
• Ability to work independently and manage multiple projects simultaneously in a deadline-driven environment.

Benefits

• Competitive salary and performance-related bonuses.
• Comprehensive health insurance and retirement savings plan.
• Generous annual leave allowance.
• Professional development opportunities and support for continuing education.
• A collaborative and dynamic work culture in the beautiful Western Cape region.