Regulatory Affairs Specialist - Pharmaceuticals

Placements24; Cape Town; Hybrid; ZAR 800,000 - 1,200,000; Full time

Benefits offered by this job

Fully remote work

Insurance package

Professional development allowance

Job summary

Placements24 is seeking a Regulatory Affairs Specialist to join a globally distributed team in a fully remote capacity. You will ensure compliance with health authority regulations for pharmaceutical products, prepare and review regulatory documentation, and manage interactions with agencies worldwide.

The role requires 4+ years in pharmaceutical regulatory affairs, knowledge of FDA/EMA/SAHPRA, and strong communication skills to navigate the complex regulatory landscape and bring medicines to

Qualifications

• Minimum of 4 years of experience in pharmaceutical regulatory affairs.
• Knowledge of global regulatory requirements (FDA, EMA, SAHPRA).
• Experience with regulatory submission software and EDMS.
• Strong understanding of drug development and lifecycle management.
• Excellent written and verbal communication skills.

Responsibilities

• Prepare and submit regulatory submissions to health authorities globally.
• Review and approve product labeling and promotional materials for regulatory compliance.
• Interpret and apply global regulatory guidelines to development and lifecycle management.
• Serve as primary contact with regulatory agencies for inquiries and submissions.
• Develop regulatory strategies for new product development and post-approval activities.
• Monitor changes in the regulatory environment and assess impact on products and operations.

Skills

Regulatory affairs knowledge

Global regulatory guidelines

Communication skills

Attention to detail

Education

Bachelor's or Master's degree in a scientific, pharmaceutical, or related discipline

Tools

Regulatory submission software

Electronic document management systems

Job description

About the Role

Our client is seeking a meticulous and knowledgeable Regulatory Affairs Specialist to join their globally distributed team, operating in a fully remote capacity. This role is crucial for ensuring compliance with all relevant health authority regulations for pharmaceutical products. You will be responsible for preparing, reviewing, and submitting regulatory documentation, and for managing interactions with regulatory agencies worldwide. This is an ideal opportunity for a self-motivated professional who thrives in an independent work setting, possesses excellent attention to detail, and is passionate about navigating the complex landscape of pharmaceutical regulations to bring vital medicines to market efficiently and compliantly.

Key Responsibilities

• Prepare and submit regulatory submissions (e.g., INDs, NDAs, CTDs) to health authorities globally.
• Review and approve product labeling, promotional materials, and advertising for regulatory compliance.
• Interpret and apply global regulatory guidelines and regulations to product development and lifecycle management.
• Serve as a primary contact with regulatory agencies for inquiries and submissions.
• Develop and implement regulatory strategies for new product development and post-approval activities.
• Monitor changes in the regulatory environment and assess their impact on the company's products and operations.

Requirements

• Bachelor's or Master's degree in a scientific, pharmaceutical, or related discipline.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs .
• In-depth knowledge of global regulatory requirements (FDA, EMA, SAHPRA, etc.).
• Experience with regulatory submission software and electronic document management systems.
• Strong understanding of drug development processes and product lifecycle management.
• Excellent written and verbal communication skills, with a keen eye for detail.

Benefits

• Competitive salary and performance-based incentives.
• Fully remote work environment with flexible hours.
• Comprehensive health, dental, and vision insurance.
• Generous allowance for professional development and continuing education.
• Opportunity to work on diverse projects and contribute to global health initiatives.