Regulatory Affairs Specialist - Pharmaceutical Compliance

Placements24; Centurion; Hybrid; ZAR 750,000 - 1,000,000; Full time

Benefits offered by this job

Competitive salary

Health and wellness benefits

Paid vacation

Professional development

Collaborative environment

Job summary

Placements24, on behalf of a respected pharmaceutical organization, seeks an experienced Regulatory Affairs Specialist to join its Centurion team. You will ensure products meet regulatory standards and manage dossiers for SAHPRA, FDA, and EMA.

You will collaborate with R&D, QA, and marketing, monitor regulatory changes, and guide lifecycle strategies, with a focus on accuracy, compliance, and timely submissions.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry or related field.
• 4+ years of experience in pharmaceutical regulatory affairs.
• Experience in preparing and submitting regulatory dossiers (CTD).
• Thorough understanding of SAHPRA, FDA and EMA regulations and guidelines.
• Excellent written and verbal communication in English.

Responsibilities

• Prepare, review, and submit regulatory documentation for new drug applications, variations, and renewals to health authorities such as SAHPRA, FDA, and EMA.
• Ensure compliance with all applicable national and international pharmaceutical regulations, guidelines, and standards.
• Liaise effectively with regulatory agencies, responding to queries and managing communications during the review process.
• Maintain up-to-date knowledge of regulatory requirements and industry best practices.
• Develop and implement regulatory strategies for product lifecycle management, including post-approval changes and annual reports.
• Conduct regulatory intelligence activities to monitor changes in the regulatory environment and assess their impact on the business.
• Review promotional materials and product labeling to ensure regulatory compliance.
• Collaborate with R&D, Quality Assurance, Marketing, and other departments to provide regulatory guidance and support.
• Manage the archiving and maintenance of regulatory records and databases.
• Participate in regulatory audits and inspections as needed.

Skills

Regulatory affairs

Dossier preparation

Regulatory strategy

Regulatory liaison

Education

Bachelor's degree in Pharmacy

Master's degree or equivalent

Tools

Regulatory information management systems

Job description

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 documentation for new drug applications, variations, and renewals to health authorities such as SAHPRA, FDA, and EMA.
• Ensure compliance with all applicable national and international pharmaceutical regulations, guidelines, and standards.
• Liaise effectively with regulatory agencies, responding to queries and managing communications during the review process.
• Maintain up-to-date knowledge of regulatory requirements and industry best practices.
• Develop and implement regulatory strategies for product lifecycle management, including post-approval changes and annual reports.
• Conduct regulatory intelligence activities to monitor changes in the regulatory environment and assess their impact on the business.
• Review promotional materials and product labeling to ensure regulatory compliance.
• Collaborate with R&D, Quality Assurance, Marketing, and other departments to provide regulatory guidance and support.
• Manage the archiving and maintenance of regulatory records and databases.
• Participate in regulatory audits and inspections as needed.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• A Master's degree or equivalent advanced qualification is a plus.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs.
• Demonstrated experience in preparing and submitting regulatory dossiers (e.g., CTD format).
• Thorough understanding of SAHPRA, FDA, and EMA regulations and guidelines.
• Excellent written and verbal communication skills, with a strong command of English.
• Proficiency in regulatory information management systems and software.
• Strong analytical and problem-solving abilities.
• Ability to manage multiple projects and meet tight deadlines in a dynamic environment.
• High level of accuracy and attention to detail.
• Experience working within a Centurion, Gauteng based pharmaceutical setting is advantageous.

Benefits

• Our client provides a competitive salary commensurate with experience, excellent health and wellness benefits, paid vacation, and opportunities for professional development.
• Be part of a dedicated team in Centurion, Gauteng, contributing to vital healthcare advancements.
• We offer a stimulating work environment with a focus on collaboration, continuous learning, and career progression.
• Employees benefit from a supportive management structure and access to industry-leading resources, ensuring a fulfilling career in pharmaceutical regulatory affairs.