Remote Pharmaceutical Regulatory Affairs Specialist

Placements24; Centurion; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive salary and performanceBonu

Comprehensive health, dental, and vis​

Remote work flexibility with home/​off

Professional development opportunities

Retirement savings plan with employer

Access to advanced collaboration tools

Supportive and inclusive remote work

Contribution to global health Initi

Job summary

Placements24 seeks an experienced Remote Pharmaceutical Regulatory Affairs Specialist to strengthen its regulatory compliance team. You will prepare and submit dossiers, monitor global guidelines, and liaise with health authorities from a fully remote capacity.

The role emphasizes independent work, cross-border collaboration, and a strong focus on compliant product lifecycle management. You will collaborate with R&D, Marketing, and other departments to ensure regulatory strategies align with

Qualifications

• Minimum of 3 years of experience in pharmaceutical regulatory affairs.
• Deep knowledge of global submission requirements (FDA, EMA, ICH).
• Experience preparing and submitting regulatory dossiers.
• Excellent written and verbal communication in English.
• Ability to work independently in a remote setting.

Responsibilities

• Prepare, compile, and submit regulatory dossiers to health authorities worldwide.
• Monitor evolving global regulatory guidelines relevant to pharmaceutical products.
• Liaise with national and international regulatory agencies to obtain approvals.
• Develop regulatory strategies for new product registrations and lifecycle management.
• Review labeling, promotional materials for regulatory compliance.
• Manage post-approval changes and reporting to authorities.
• Maintain regulatory databases and records.

Skills

Regulatory submissions

Dossier preparation

Regulatory intelligence

English communication

Education

Bachelor's or Master's in Pharmacy/ Chemistry/ Life Sciences

Job description

About the Role

Our client, a distinguished pharmaceutical company recognized for its commitment to global health advancements, is seeking an experienced Remote Pharmaceutical Regulatory Affairs Specialist to strengthen its regulatory compliance team. This role is designed for a professional who can operate effectively in a fully remote capacity, ensuring our products meet all necessary regulatory requirements across diverse international markets. You will be instrumental in navigating complex regulatory landscapes, preparing submission dossiers, and liaising with health authorities. Our client prides itself on fostering a culture of integrity, innovation, and continuous improvement, and this position is key to upholding those values. We are looking for a detail-oriented, proactive individual with a deep understanding of pharmaceutical regulations and a proven ability to manage multiple projects simultaneously. The opportunity to contribute to bringing essential medicines to patients globally, while enjoying the flexibility of a remote work environment, makes this a highly attractive position. You will collaborate with various internal departments and external partners, ensuring seamless regulatory processes from development through to post-market surveillance, all managed through advanced digital collaboration tools. Our commitment to employee well-being and professional growth is paramount, even in a distributed team structure.

Key Responsibilities

• Prepare, compile, and submit regulatory dossiers (e.g., CTD, IND, NDA, MAA) to health authorities worldwide.
• Monitor and interpret evolving global regulatory requirements and guidelines relevant to pharmaceutical products.
• Liaise with national and international regulatory agencies to facilitate product approvals and address queries.
• Develop and implement regulatory strategies for new product registrations and lifecycle management.
• Review and approve product labeling, promotional materials, and advertising content for regulatory compliance.
• Manage post-approval changes and ensure timely reporting to regulatory authorities.
• Conduct regulatory intelligence activities to stay informed about competitor filings and market trends.
• Advise R&D, Marketing, and other departments on regulatory requirements and submission strategies.
• Maintain regulatory databases and ensure accurate record-keeping of all regulatory activities.
• Participate in cross-functional teams to support product development and commercialization efforts.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum of 3 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of global regulatory submission requirements and guidelines (e.g., FDA, EMA, ICH).
• Proven experience in preparing and submitting regulatory dossiers.
• Excellent written and verbal communication skills, with a strong command of English.
• Demonstrated ability to work independently and manage multiple priorities effectively in a remote setting.
• Strong analytical and problem-solving skills.
• Proficiency in regulatory information management systems and MS Office Suite.
• Ability to collaborate effectively with internal and external stakeholders across different time zones.
• Detail-oriented with a high degree of accuracy.

Benefits

• Competitive salary and potential for performance bonuses.
• Comprehensive health, dental, and vision insurance.
• Remote work flexibility with a dedicated home office stipend.
• Opportunities for professional development and continuing education.
• Retirement savings plan with employer matching.
• Access to advanced collaboration tools and technologies.
• Supportive and inclusive remote work culture.
• Contribution to significant global health initiatives through product approvals.