Regulatory Affairs Specialist - Global Submissions

Placements24; Rustenburg; Hybrid; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Competitive salary

Health and dental insurance

Flexible remote work

PTO and professional development

Impact global health

Job summary

Placements24 is seeking a Regulatory Affairs Specialist to support pharmaceutical operations from a remote setting. You will prepare and submit regulatory documentation to health authorities worldwide, ensuring compliance with FDA, EMA, and ICH guidelines.

Ideal candidates have a minimum of 5 years experience in regulatory affairs and strong written/verbal communication skills. The role offers a fully remote arrangement within South Africa, with competitive compensation and benefits.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, or related field.
• Minimum of 5 years in pharmaceutical regulatory affairs with global submissions.
• Strong knowledge of FDA, EMA, ICH guidelines and dossier filing.

Responsibilities

• Prepare, review, and submit regulatory submissions to health authorities worldwide.
• Maintain compliance with evolving global regulatory requirements.
• Manage post-approval commitments and lifecycle activities.
• Coordinate with R&D, Manufacturing, Clinical teams and external partners.
• Respond to agency queries in a timely and comprehensive manner.
• Support regulatory strategies for new registrations and lifecycle management.

Skills

Regulatory affairs

Global submissions

Regulatory guidelines

Dossier filing

Autonomous work

Education

Bachelor's degree in Pharmacy, Life Sciences, or related field

Job description

About the Role

Our client is actively seeking a dedicated Regulatory Affairs Specialist to join their global team, working remotely to support their extensive pharmaceutical operations. In this vital role, you will be responsible for preparing and submitting regulatory documentation to health authorities worldwide, ensuring compliance with diverse international regulations. This position is ideal for a detail-oriented professional with a proven track record in regulatory affairs who thrives in a remote work environment. You will play a crucial part in navigating the complex global regulatory landscape, enabling our client to bring essential medicines to patients across the globe from their base in Klerksdorp .

Key Responsibilities

• Prepare, review, and submit high-quality regulatory submissions (e.g., INDs, NDAs, MAAs, variations) to various international health authorities.
• Maintain regulatory compliance by staying current with evolving global regulatory requirements and guidelines.
• Manage post-approval regulatory commitments, including annual reports and lifecycle management activities.
• Liaise effectively with internal departments (R&D, Manufacturing, Clinical) and external partners to gather necessary information for submissions.
• Respond to queries from regulatory agencies in a timely and comprehensive manner.
• Contribute to the development and implementation of regulatory strategies for new product registrations and lifecycle management, supporting the organization's reach beyond Klerksdorp .

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, or a related field; advanced degree is a plus.
• Minimum of 5 years of experience in pharmaceutical regulatory affairs , with a focus on global submissions.
• In-depth knowledge of international regulatory guidelines and submission requirements (e.g., FDA, EMA, ICH).
• Proven experience in preparing and filing various types of regulatory dossiers.
• Excellent written and verbal communication skills, with meticulous attention to detail.
• Ability to work autonomously, manage multiple projects, and meet strict deadlines in a remote setting.

Benefits

• Competitive salary and performance-based incentives.
• Comprehensive health, dental, and vision insurance.
• Flexible working hours and a robust remote work infrastructure.
• Generous paid time off and professional development opportunities.
• The chance to make a significant impact on global health from the comfort of your home office.