Pharmaceutical Regulatory Affairs Specialist

Placements24; Gqeberha; Hybrid; ZAR 700,000 - 1,100,000; Full time

Benefits offered by this job

Medical benefits

Retirement plan

Remote work flexibility

Professional development

Job summary

Placements24 is seeking a proactive Pharmaceutical Regulatory Affairs Specialist, ideally based in or near Port Elizabeth, with remote work flexibility. You will prepare and submit regulatory dossiers (CTD/ANDA), liaise with health authorities, and guide products through lifecycle compliance to achieve timely market access.

The role requires a Bachelor’s in Pharmacy or related field and 4+ years in Regulatory Affairs, with experience in electronic submissions and regulatory information systems.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry or related field.
• Minimum 4 years of experience in pharmaceutical Regulatory Affairs.
• Strong understanding of regulatory submission processes and guidelines in key markets.
• Experience with electronic submission formats and regulatory information management systems.
• Excellent written and verbal communication, with strong attention to detail.
• Ability to work independently in a remote setting and manage multiple projects.

Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD, ANDA) to health authorities such as SAHPRA.
• Ensure compliance with all applicable regulatory requirements and guidelines throughout the product lifecycle.
• Communicate effectively with regulatory agencies, responding to queries and addressing concerns.
• Monitor changes in the regulatory environment and assess their impact on company products and strategies.
• Collaborate with R&D, manufacturing, and marketing teams to provide regulatory guidance and support.
• Maintain regulatory documentation and databases, ensuring accuracy and completeness.

Skills

Regulatory affairs

Regulatory submissions

Communication

Remote work

Education

Bachelor's degree in Pharmacy/Life Sciences/Chemistry

Tools

Regulatory submissions software

Job description

About the Role

Our client is seeking a proactive and knowledgeable Pharmaceutical Regulatory Affairs Specialist to join their team, ideally based in or near Port Elizabeth , with the flexibility of remote work. This role is essential for ensuring that all company products comply with national and international regulatory standards, facilitating timely product approvals and market access. You will be responsible for preparing and submitting regulatory dossiers, liaising with health authorities, and staying abreast of evolving regulatory landscapes. This position offers the chance to contribute to global health by navigating complex regulatory pathways and ensuring the successful launch of innovative pharmaceutical products.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD, ANDA) to health authorities such as SAHPRA.
• Ensure compliance with all applicable regulatory requirements and guidelines throughout the product lifecycle.
• Communicate effectively with regulatory agencies, responding to queries and addressing concerns.
• Monitor changes in the regulatory environment and assess their impact on company products and strategies.
• Collaborate with R&D, manufacturing, and marketing teams to provide regulatory guidance and support.
• Maintain regulatory documentation and databases, ensuring accuracy and completeness.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• Minimum of 4 years of experience in pharmaceutical Regulatory Affairs .
• Strong understanding of regulatory submission processes and guidelines in key markets.
• Experience with electronic submission formats and regulatory information management systems.
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to work independently in a remote setting and manage multiple projects effectively.

Benefits

• Competitive annual salary with performance-based incentives.
• Remote work flexibility, allowing for a comfortable and efficient work environment.
• Comprehensive medical, dental, and retirement benefits.
• Opportunities for professional development and growth in a dynamic field.
• A supportive team that values collaboration and expertise in regulatory compliance.