Senior Pharmaceutical Regulatory Affairs Specialist

Placements24; Vereeniging; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Medical insurance

Retirement savings plan

Paid time off

Relocation assistance

Job summary

Placements24 is seeking an experienced Senior Pharmaceutical Regulatory Affairs Specialist to join its strategic team in Vereeniging, Gauteng. The role focuses on ensuring products meet global regulatory requirements and developing submission strategies for SAHPRA, FDA, and EMA.

You will lead regulatory submissions (CTD/ANDA/NDA), liaise with authorities, and guide cross-functional teams through the development and post-approval lifecycle, with opportunities for professional growth and

Qualifications

• Bachelor's degree in Pharmacy or life sciences; advanced degree preferred.
• 5–7 years in pharma regulatory affairs.
• Knowledge of ICH, FDA, EMA, SAHPRA guidelines.
• Experience with regulatory dossiers for various dosage forms.

Responsibilities

• Develop global regulatory strategies for new products and lifecycle management.
• Prepare and submit CTD/ANDA/NDA dossiers to authorities.
• Liaise with regulators and manage submission communications.
• Ensure labeling and promotional materials comply with regs.
• Provide regulatory guidance to R&D, manufacturing, QA, and marketing.
• Support post-approval variations and annual reports.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Regulatory intelligence

Project management

Communication

Education

Bachelor's degree in Pharmacy/life science

Master's or Ph.D. preferred

Tools

Gateway

eCTD

Job description

About the Role

Our client, a rapidly expanding pharmaceutical enterprise, is seeking an experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their strategic team in Vereeniging . This role is paramount in ensuring that all pharmaceutical products meet the stringent regulatory requirements of various global health authorities, including SAHPRA, FDA, and EMA. The successful candidate will be responsible for developing regulatory strategies, preparing submission dossiers, and liaising with regulatory bodies to secure product approvals and maintain compliance. This is an outstanding opportunity to leverage your regulatory expertise within the thriving pharmaceutical sector of Gauteng , specifically in Vereeniging . We are looking for a proactive individual with a proven track record in navigating complex regulatory landscapes and a passion for bringing innovative medicines to market.

Key Responsibilities

• Develop and implement global regulatory strategies for new product development and lifecycle management.
• Prepare, review, and submit regulatory dossiers (e.g., CTD, ANDA, NDA) to health authorities worldwide.
• Serve as the primary point of contact with regulatory agencies, responding to queries and managing communications throughout the submission and review process.
• Ensure all product labeling and promotional materials comply with regulatory requirements.
• Monitor changes in the regulatory environment and assess their impact on the company's products and strategies.
• Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, quality assurance, and marketing.
• Maintain regulatory compliance for approved products, including post-approval variations and annual reports.
• Conduct regulatory intelligence activities to identify emerging trends and requirements.
• Participate in regulatory inspections and audits as needed.
• Manage intellectual property related to regulatory submissions.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field; advanced degree (Master's or Ph.D.) is preferred.
• Minimum of 5-7 years of progressive experience in pharmaceutical regulatory affairs.
• Demonstrated experience in preparing and submitting regulatory dossiers for various dosage forms and markets.
• In-depth knowledge of global regulatory requirements (e.g., ICH, FDA, EMA, SAHPRA) and guidelines.
• Excellent understanding of drug development processes, manufacturing, and quality systems.
• Strong analytical, organizational, and project management skills.
• Exceptional written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
• Proven ability to work independently and effectively in a team-oriented environment.
• Experience with electronic submission systems (e.g., Gateway, eCTD) is essential.
• Strategic thinking and problem-solving capabilities.

Benefits

• Our client offers a highly competitive salary and a comprehensive benefits package, including robust medical, dental, and vision insurance, a retirement savings plan, and performance bonuses.
• We are committed to your professional development, providing access to industry training, conferences, and opportunities for career advancement.
• Generous paid time off, including vacation, sick leave, and holidays, is provided.
• Additional benefits encompass life insurance, disability coverage, and potential relocation assistance for candidates moving to Vereeniging .
• Join a dedicated team and play a vital role in bringing essential medicines to patients worldwide.