Regulatory Affairs Specialist - Pharmaceuticals

Placements24; Kimberley; On-site; CAD 51,000 - 102,000; Full time

Benefits offered by this job

Competitive salary and incentives

Comprehensive health insurance

Retirement plan

Professional development support

Collaborative work environment

Job summary

Placements24 is seeking a detail-oriented Regulatory Affairs Specialist to manage regulatory activities for pharmaceutical products in Kimberley. You will ensure compliance with national and international requirements from registration to post-market surveillance, enabling timely approvals and market access.

The role requires deep knowledge of regulatory submissions and guidelines, and a proactive approach within a collaborative team focused on regulatory excellence in Kimberley.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry or related field.
• Minimum 4 years of pharmaceutical regulatory affairs experience.
• Knowledge of regulatory submissions in SA and international markets.
• Experience with regulatory databases and submission software.
• Strong analytical, problem-solving and communication skills.

Responsibilities

• Prepare, submit and manage regulatory applications for product registration and variations.
• Ensure compliance with local and international pharmaceutical regulations and guidelines.
• Liaise with regulatory authorities on submission status and inquiries.
• Review and approve promotional materials for regulatory compliance.
• Monitor regulatory changes and assess impact on products and operations.

Skills

Analytical thinking

Problem-solving

Communication

Regulatory knowledge

Education

Bachelor's degree in Pharmacy or Life Sciences

Tools

Regulatory databases

Submission software

Job description

About the Role

Our client is seeking a detail-oriented and experienced Regulatory Affairs Specialist to manage and coordinate regulatory activities for their pharmaceutical products in Kimberley . You will be responsible for ensuring that all products comply with national and international regulatory requirements, from product registration to post-market surveillance. This role requires a deep understanding of regulatory submissions, guidelines, and a proactive approach to navigating the complex regulatory landscape. The ideal candidate will be instrumental in facilitating the timely approval and market access of new and existing pharmaceutical products, working within a dedicated team committed to regulatory excellence in Kimberley .

Key Responsibilities

• Prepare, submit, and manage regulatory applications for product registration and variations.
• Ensure compliance with all relevant local and international pharmaceutical regulations and guidelines.
• Liaise with regulatory authorities (e.g., SAHPRA) on submission status and inquiries.
• Review and approve promotional materials to ensure regulatory compliance.
• Monitor changes in regulatory legislation and assess their impact on the company's products and operations.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of regulatory submission processes and requirements in South Africa and key international markets.
• Experience with regulatory databases and submission software.
• Strong analytical, problem-solving, and communication skills.

Benefits

• Competitive salary and performance-based incentives.
• Comprehensive health insurance and retirement plan.
• Support for professional development and regulatory training.
• A collaborative work environment with opportunities for growth.
• Key role in ensuring compliance and market access for pharmaceuticals in Kimberley .