Pharmaceutical Regulatory Affairs Manager

Placements24; Centurion; Hybrid; ZAR 1,200,000 - 2,000,000; Full time

Benefits offered by this job

Health & wellness programs

Retirement planning options

Performance-driven incentives

Training & conferences

Global project exposure

Job summary

Placements24 seeks a Pharmaceutical Regulatory Affairs Manager for a fully remote role leading regulatory strategy and global submissions. You will guide cross-functional teams across R&D, manufacturing, and commercial to ensure compliant submissions and timely product access.

The ideal candidate holds an advanced degree and 8+ years of regulatory experience, with deep knowledge of SAHPRA, FDA, and EMA processes, and a proven track record in strategic regulatory planning and lifecycle management.

Qualifications

• Advanced degree in Pharmacy, Chemistry, Biology, or related science.
• 8+ years in pharmaceutical regulatory affairs with global submissions track record.
• Deep understanding of SAHPRA, US FDA, EMA regulatory requirements.
• Experience developing and executing regulatory strategies for NME and existing products.
• Strong analytical, problem-solving, and communication skills.

Responsibilities

• Develop and implement global regulatory strategies for NDAs/MAAs and variations.
• Prepare, review, and submit high-quality regulatory dossiers to SAHPRA, FDA, EMA, and others.
• Provide regulatory guidance to R&D, clinical, manufacturing, and commercial teams.
• Monitor evolving regulatory landscapes and advise strategically.
• Manage lifecycle regulatory activities: post-approval changes, annual reports, safety updates.
• Lead regulatory interactions with health authorities (pre-submission meetings, deficiency letters).
• Ensure regulatory compliance throughout product lifecycle and policies.
• Oversee labeling and promotional materials for compliance.

Skills

Regulatory strategy

Global submissions

Cross-functional leadership

Regulatory guidance

Drug development

Education

Masters or PhD in Pharmaceutical Science

Tools

Regulatory databases

Submission software

Job description

About the Role

Our client, a globally recognized pharmaceutical company, is actively seeking an accomplished Pharmaceutical Regulatory Affairs Manager to lead their regulatory strategy. This is a fully remote position, offering unparalleled flexibility while maintaining a critical role in bringing innovative medicines to market. The successful candidate will be responsible for developing and executing regulatory submissions, ensuring compliance with all relevant health authority regulations across key markets. This role demands a strategic thinker with extensive experience in navigating complex regulatory landscapes. You will play a crucial part in shaping the future of our client's product portfolio and ensuring timely access to essential treatments for patients worldwide. This remote position requires a high degree of self-discipline and proactive engagement. You will be a key advisor on all regulatory matters, impacting product lifecycle management and market entry strategies.

Key Responsibilities

• Develop and implement global regulatory strategies for new drug applications (NDAs), marketing authorization applications (MAAs), and variations.
• Prepare, review, and submit high-quality regulatory dossiers to health authorities such as the SAHPRA, FDA, EMA, and others.
• Provide regulatory guidance and expertise to cross-functional teams, including R&D, clinical development, manufacturing, and commercial operations.
• Monitor and interpret evolving regulatory landscapes and provide proactive strategic advice to the organization.
• Manage lifecycle regulatory activities, including post-approval changes, annual reports, and safety updates.
• Lead regulatory interactions with health authorities, including pre-submission meetings and deficiency letter responses.
• Ensure compliance with all applicable regulations, guidelines, and company policies throughout the product lifecycle.
• Contribute to the development and implementation of regulatory policies and procedures.
• Oversee the preparation and review of labeling and promotional materials for regulatory compliance.

Requirements

• Advanced degree (Master's or Ph.D.) in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• A minimum of 8 years of experience in pharmaceutical regulatory affairs, with a proven track record of successful global submissions.
• Deep understanding of regulatory requirements in major markets (e.g., South Africa, US, Europe).
• Demonstrated experience in regulatory strategy development and execution for both new molecular entities and existing products.
• Excellent knowledge of drug development processes and pharmaceutical manufacturing.
• Strong analytical, problem-solving, and communication skills.
• Proven ability to manage complex projects and lead cross-functional teams in a remote setting.
• Experience with regulatory submission software and databases.
• Ability to work independently, manage time effectively, and meet aggressive deadlines.
• Must be able to work remotely and maintain high levels of productivity and collaboration.

Benefits

As a fully remote position, our client offers significant flexibility and autonomy. The compensation package is highly competitive, reflecting the strategic importance of this role.

• benefits include comprehensive health and wellness programs, generous retirement planning options, and performance-driven incentives.
• We invest in our employees' professional growth through continuous training, conference attendance, and opportunities to work on challenging global projects.

This role provides the unique advantage of contributing to global health outcomes from the comfort of your home, with robust support systems in place to ensure seamless remote collaboration and success. Enjoy the benefits of working with a forward-thinking company from anywhere in South Africa .