Pharmaceutical Regulatory Affairs Specialist - Welkom

Placements24; Willows (CA); Hybrid; USD 46,000 - 70,000; Full time

Benefits offered by this job

Medical aid

Pension fund

Hybrid role in Welkom

Job summary

Placements24 in Welkom is seeking an experienced Pharmaceutical Regulatory Affairs Specialist to ensure compliance with national and international regulations. You will prepare and submit regulatory dossiers, liaise with health authorities, and monitor evolving guidelines to keep products on track for approval.

The role demands a strong grasp of SAHPRA processes, ICH guidelines, and meticulous documentation, with collaboration across R&D, QA, and marketing.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or related field.
• Master’s degree or regulatory qualification advantageous.
• Minimum 4 years regulatory affairs experience with SA regulatory landscape.
• Experience preparing regulatory dossiers and submissions.
• Knowledge of ICH guidelines and submission requirements.
• Excellent attention to detail and organizational skills.
• Strong communication and stakeholder management.
• Proficiency with regulatory information systems and office software.

Responsibilities

• Prepare, review, and submit regulatory filings, including marketing authorization applications, variations, and renewals, to SAHPRA and other authorities.
• Ensure all regulatory documentation is accurate, complete, and compliant with current guidelines.
• Liaise directly with regulatory agencies to address queries and facilitate approvals.
• Monitor regulatory changes and assess impact on products and strategies.
• Develop and maintain regulatory strategies for new product development and lifecycle management.
• Collaborate with cross-functional teams to provide regulatory guidance and support.
• Maintain regulatory submission databases and track approvals.

Skills

Regulatory knowledge

Dossier submission

Regulatory strategy

Cross-functional collaboration

Education

Bachelor's degree in Pharmacy or related field

Tools

Regulatory Information Management System (RIMS)

Job description

About the Role

Our client, a rapidly growing pharmaceutical company, is seeking an experienced Pharmaceutical Regulatory Affairs Specialist to join their dedicated team in Welkom. This crucial role involves ensuring that all company products comply with national and international regulatory requirements. You will be responsible for preparing and submitting regulatory documentation, liaising with health authorities, and staying current with evolving regulatory landscapes. The ideal candidate will possess a strong understanding of pharmaceutical regulations and a meticulous approach to documentation. This is an excellent opportunity to play a key part in bringing essential medicines to market and ensuring patient safety. Our client values accuracy, compliance, and strategic thinking, offering a collaborative environment for professional development in the dynamic field of pharmaceutical regulation.

Key Responsibilities

• Prepare, review, and submit regulatory filings, including marketing authorization applications, variations, and renewals, to relevant health authorities (e.g., SAHPRA).
• Ensure all regulatory documentation is accurate, complete, and compliant with current guidelines.
• Liaise directly with regulatory agencies to address queries, provide additional information, and facilitate the approval process.
• Monitor and interpret changes in the regulatory environment, assessing their impact on company products and strategies.
• Develop and maintain regulatory strategies for new product development and lifecycle management.
• Collaborate with cross-functional teams (e.g., R&D, Quality Assurance, Marketing) to provide regulatory guidance and support.
• Maintain regulatory databases and ensure the accurate tracking of submissions and approvals.
• Conduct regulatory intelligence activities to identify emerging trends and requirements.
• Participate in regulatory audits and inspections as needed.
• Contribute to the continuous improvement of regulatory processes and systems.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• A Master's degree or specialized regulatory affairs qualification is advantageous.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs, with a strong understanding of the South African regulatory landscape.
• Proven experience in preparing and submitting regulatory dossiers for various pharmaceutical products.
• In-depth knowledge of pharmaceutical regulations, guidelines (e.g., ICH), and submission requirements.
• Excellent attention to detail and strong organizational skills.
• Effective communication and interpersonal skills, with the ability to interact professionally with regulatory authorities and internal stakeholders.
• Proficiency in regulatory information management systems and standard office software.
• Ability to work independently, manage multiple projects, and meet tight deadlines.
• Problem-solving skills and a proactive approach to regulatory challenges.
• Adaptability to evolving regulatory requirements and a commitment to compliance.

Benefits

Our client offers a competitive salary and benefits package, including medical aid, pension fund, and opportunities for professional development and training in regulatory affairs. This hybrid role, based in Welkom, allows for a blend of in-office collaboration and remote flexibility. You will be part of a supportive team environment where your expertise in regulatory compliance is highly valued. Our client is committed to fostering a culture of excellence and providing pathways for career growth within the pharmaceutical industry.