Remote Pharmaceutical Regulatory Affairs Specialist

Placements24; Richards Bay; À distance; ZAR 900 000 - 1 200 000; Plein temps

Avantages offerts par ce poste

Fully remote role

Résumé du poste

Placements24 is seeking a highly motivated Remote Pharmaceutical Regulatory Affairs Specialist to support global submissions from anywhere. You will navigate international regulatory requirements and work across R&D, Manufacturing, and Marketing to ensure compliance.

This fully remote role emphasizes strategic regulatory planning, timely dossiers (CTD/IND/NDA/MAA), and proactive liaison with health authorities to drive product approvals worldwide.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry or related field required.
• Minimum of 5 years in pharmaceutical regulatory affairs.
• Experience submitting regulatory applications in major markets (US, EU, etc.).

Responsabilités

• Prepare, review, and submit regulatory dossiers to health authorities globally.
• Interpret regulatory guidelines (ICH, FDA, EMA, SAHPRA) to product development.
• Develop regulatory strategies for registration and lifecycle maintenance.
• Liaise with regulatory agencies, respond to queries and manage interactions.
• Monitor regulatory environment changes and assess impact on products.
• Conduct regulatory due diligence for BD activities and acquisitions.
• Review labeling, advertising, and promotional materials for compliance.
• Collaborate with R&D, Clinical, Marketing, and Manufacturing teams.
• Maintain regulatory databases and ensure accuracy of information.

Connaissances

Regulatory affairs

Regulatory submissions

Analytical skills

Project management

Communication skills

Formation

Bachelor's degree in Pharmacy/Life Sciences/Chemistry

Outils

Regulatory information management systems

Description du poste

About the Role

Our client, a global pharmaceutical company dedicated to improving global health outcomes, is seeking a highly motivated and experienced Remote Pharmaceutical Regulatory Affairs Specialist. This position is a fully remote role, offering the flexibility to work from anywhere while contributing to critical regulatory submissions and strategies. You will be responsible for ensuring our products meet the diverse regulatory requirements across various international markets. The ideal candidate possesses a deep understanding of global regulatory landscapes, strong analytical skills, and an exceptional ability to navigate complex compliance frameworks. Join a forward-thinking team that embraces remote work to foster talent and productivity, making a tangible impact on healthcare worldwide from your home office.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD, IND, NDA, MAA) to health authorities globally.


• Interpret and apply regulatory guidelines (ICH, FDA, EMA, SAHPRA, etc.) to product development and lifecycle management.


• Develop regulatory strategies for product registration and lifecycle maintenance.


• Liaise with regulatory agencies, respond to queries, and manage regulatory interactions.


• Monitor changes in the regulatory environment and assess their impact on company products and strategies.


• Conduct regulatory due diligence for potential business development activities and acquisitions.


• Review labeling, advertising, and promotional materials for compliance with relevant regulations.


• Collaborate with internal teams (R&D, Clinical, Marketing, Manufacturing) to ensure alignment on regulatory requirements.


• Maintain regulatory databases and ensure the accuracy of regulatory information.

Requirements

Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field; advanced degree preferred. Minimum of 5 years of experience in pharmaceutical regulatory affairs. Proven experience in preparing and submitting various types of regulatory applications in major markets (US, EU, etc.). In-depth knowledge of global regulatory guidelines and submission processes. Excellent understanding of drug development lifecycle and manufacturing processes. Strong analytical, organizational, and project management skills. Exceptional written and verbal communication skills, with a keen eye for detail. Ability to work independently and manage multiple projects simultaneously in a remote setting. Proficiency in regulatory information management systems and common office software.

Benefits

• competitive annual salary, performance-based bonuses, comprehensive health benefits package, a home office stipend, and access to online professional development resources

Our client is committed to supporting its remote workforce with the tools and opportunities needed for success and career growth. Enjoy the flexibility of working from anywhere while contributing to a globally impactful organization.