Regulatory Affairs Specialist - Pharmaceutical Compliance

Placements24; Willows (CA); On-site; USD 36,000 - 54,000; Full time

Job summary

Placements24 is seeking a Regulatory Affairs Specialist for a distinguished pharmaceutical company in Welkom, South Africa. The role focuses on ensuring compliance with SAHPRA and international guidelines, including dossier preparation and submissions throughout the product lifecycle.

You will collaborate with R&D, QA, and Marketing to gather information, monitor regulatory changes, and guide project teams on submissions and labeling changes. A strong background in CTD submissions is required.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or related field.
• Minimum 4 years in pharmaceutical regulatory affairs with SAHPRA knowledge.
• Experience preparing and submitting CTD dossiers.
• Strong attention to detail and communication skills.
• Based in Welkom or able to commute.

Responsibilities

• Prepare, review, and submit regulatory submissions for pharmaceutical products.
• Ensure submissions are accurate, complete, and compliant with guidelines and standards.
• Maintain regulatory databases and filings; keep information current and accessible.
• Monitor regulatory changes and assess impact on products and operations.
• Manage post-approval commitments, including advertising and promotion compliance.
• Liaise with regulatory authorities and facilitate inspections.

Skills

Regulatory affairs

CTD submissions

Dossier preparation

Regulatory intelligence

Cross-functional collaboration

Education

Bachelor's degree in Pharmacy, Chemistry, Life Sciences

Tools

Regulatory databases

Job description

About the Role

Our client, a distinguished pharmaceutical company with a significant market presence, is seeking a diligent and knowledgeable Regulatory Affairs Specialist to enhance their compliance operations in Welkom, Free State . This role is crucial for ensuring that all pharmaceutical products and associated documentation meet the stringent requirements of regulatory bodies such as the South African Health Products Regulatory Authority (SAHPRA) and other international agencies. You will be responsible for preparing and submitting regulatory dossiers, managing post-approval changes, and maintaining compliance throughout the product lifecycle. This is an exceptional opportunity to build a rewarding career in regulatory affairs within an organisation committed to ethical practices and scientific excellence.

Key Responsibilities

• Prepare, review, and submit regulatory submissions (e.g., new marketing authorizations, variations, renewals) for pharmaceutical products.
• Ensure all submissions are accurate, complete, and compliant with current regulatory guidelines and company standards.
• Maintain and update regulatory databases and filings, ensuring all information is current and accessible.
• Monitor changes in the regulatory landscape and assess their impact on company products and operations.
• Manage post-approval commitments, including advertising and promotion compliance.
• Liaise with regulatory authorities, respond to queries, and facilitate inspections.
• Collaborate with internal departments (e.g., R&D, Quality Assurance, Marketing) to gather necessary information for submissions and ensure alignment.
• Provide regulatory guidance and support to project teams throughout the product development lifecycle.
• Evaluate and manage labeling and artwork changes in accordance with regulatory requirements.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs, with a strong understanding of South African regulatory requirements (SAHPRA).
• Proven experience in preparing and submitting Common Technical Document (CTD) dossiers.
• Knowledge of global regulatory guidelines and submission strategies.
• Excellent attention to detail and accuracy in reviewing technical and scientific documents.
• Strong analytical and problem-solving skills.
• Effective written and verbal communication skills, with the ability to negotiate and influence.
• Proficiency in regulatory information management systems and standard office software.
• Ability to manage multiple projects simultaneously and meet strict deadlines.
• Must be legally authorized to work in South Africa and be based in or able to commute to Welkom .

Benefits

• Competitive salary and potential for performance-based incentives.
• Comprehensive health insurance coverage and retirement savings options.
• Professional development programs and opportunities for career advancement.
• A supportive and collaborative work environment.
• Exposure to diverse product portfolios and regulatory challenges.
• Paid time off and public holidays.