Senior Pharmaceutical Regulatory Affairs Specialist

Placements24; Rustenburg; On-site; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Competitive salary

Remote work

Healthcare

Retirement planning

Life insurance

Growth opportunities

Job summary

Placements24 seeks a seasoned Senior Pharmaceutical Regulatory Affairs Specialist to guide regulatory compliance for products manufactured in Rustenburg and distributed internationally, with remote work and significant autonomy.

You will develop regulatory strategies, prepare CTD dossiers, and advise project teams on regulatory implications, ensuring timely submissions and successful interactions with health authorities.

Qualifications

• Bachelors or Masters in Pharmacy, Chemistry, Life Sciences, or related field.
• Minimum 5–7 years of pharmaceutical regulatory affairs experience.
• Experience preparing and submitting registration dossiers (CTD Module 3).
• Familiar with regulatory submission software and databases.

Responsibilities

• Develop and execute regulatory strategies for global product registrations and lifecycle management.
• Prepare, review, and submit CTD dossiers to SAHPRA, FDA, EMA, and other authorities.
• Liaise with agencies, respond to queries, and support inspections.
• Monitor regulatory changes and advise on impact to products and plans.
• Provide regulatory input to development, manufacturing, and commercial teams.
• Ensure promotional materials and labeling comply with guidelines.

Skills

Regulatory strategy

Regulatory submissions

Stakeholder liaison

Regulatory compliance

Education

Pharmacy or Life Sciences degree

Job description

About the Role

Our client seeks a seasoned Senior Pharmaceutical Regulatory Affairs Specialist to provide expert guidance and ensure compliance with regulatory requirements for their products manufactured and distributed in Rustenburg and internationally. This role is crucial for navigating the complex landscape of pharmaceutical regulations, ensuring timely submissions, and maintaining positive relationships with health authorities. You will be responsible for developing regulatory strategies, preparing submission dossiers, and advising project teams on regulatory implications. This is an ideal position for a proactive professional who thrives on ensuring global compliance within the dynamic pharmaceutical industry, working remotely with significant autonomy.

Key Responsibilities

• Develop and execute regulatory strategies for new product registrations and lifecycle management in various global markets.
• Prepare, review, and submit regulatory documentation (e.g., CTD, IND, NDA) to health authorities such as the SAHPRA, FDA, and EMA.
• Liaise with regulatory agencies, responding to queries and facilitating agency inspections and interactions.
• Monitor changes in the regulatory landscape and assess their impact on the company's products and strategies.
• Provide regulatory input and support to product development, manufacturing, and commercial teams.
• Ensure all promotional materials and labeling comply with relevant regulatory guidelines.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum 5-7 years of experience in pharmaceutical regulatory affairs, with a strong understanding of South African and international regulatory requirements.
• Proven experience in preparing and submitting registration dossiers (e.g., Module 3 of the CTD).
• Familiarity with regulatory submission software and databases.
• Excellent written and verbal communication skills, with the ability to negotiate effectively with regulatory bodies.

Benefits

• Competitive annual salary with performance-based incentives.
• Remote work flexibility, allowing you to work from anywhere.
• Comprehensive healthcare, retirement planning, and life insurance.
• Opportunities for professional growth, including attending international regulatory conferences.
• A supportive and collaborative remote team environment focused on global health solutions.