Pharmaceutical Regulatory Affairs Manager

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

Benefits offered by this job

Health insurance

Professional development

Hybrid work model

Performance incentives

Job summary

Placements24 is seeking a Pharmaceutical Regulatory Affairs Manager in Richards Bay to lead regulatory strategies, submissions, and interactions with health authorities. This hybrid role requires strategic thinking and meticulous attention to detail to ensure market authorization and lifecycle compliance.

You will collaborate with R&D, manufacturing, and marketing to align regulatory plans with business objectives, monitor global changes, and guide cross-functional teams through CTD submissions

Qualifications

• Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences or related field.
• Minimum 5 years of pharmaceutical regulatory affairs experience.
• Proven experience preparing and submitting marketing authorization applications.
• Deep knowledge of global regulatory requirements and submission processes.
• Strong strategic thinking, analytical and communication skills.
• Ability to manage multiple projects in a cross-functional team environment.

Responsibilities

• Develop and implement regulatory strategies for product registration and lifecycle management across markets.
• Prepare, review, and submit regulatory dossiers (CTD format) to health authorities.
• Serve as primary contact with regulatory agencies, responding to queries and managing submissions.
• Ensure compliance with local and international pharmaceutical regulations and standards.
• Provide regulatory input to R&D, manufacturing, marketing and other departments.
• Monitor regulatory changes and assess impact on products and operations.

Skills

Regulatory strategy

Dossier submission

Regulatory liaison

Cross-functional collaboration

Pharmaceutical regulations

Strategic thinking

Education

Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences

Tools

CTD format

Job description

About the Role

Our client is looking for a strategic and detail-oriented Pharmaceutical Regulatory Affairs Manager to join their team in Richards Bay . This hybrid role is essential for navigating the complex regulatory landscape and ensuring that our pharmaceutical products meet all necessary compliance standards for market authorization and ongoing lifecycle management. You will lead regulatory submission efforts, liaise with health authorities, and provide expert guidance on regulatory strategies to support business objectives, working closely with cross-functional teams to maintain compliance and facilitate product approvals.

Key Responsibilities

• Develop and execute regulatory strategies for product registration and lifecycle management in various markets.
• Prepare, review, and submit regulatory dossiers (e.g., CTD format) to health authorities.
• Serve as the primary point of contact with regulatory agencies, responding to queries and managing submissions.
• Ensure compliance with local and international pharmaceutical regulations, guidelines, and standards.
• Provide regulatory input and guidance to R&D, manufacturing, marketing, and other departments.
• Monitor regulatory changes and assess their impact on the company's products and operations.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum of 5 years of experience in pharmaceutical regulatory affairs.
• Proven experience in preparing and submitting marketing authorization applications.
• In-depth knowledge of global regulatory requirements and submission processes.
• Excellent strategic thinking, analytical, and communication skills.
• Ability to manage multiple projects and work effectively in a cross-functional team environment.

Benefits

• Competitive annual salary and performance-based incentives.
• Comprehensive health, dental, and vision insurance.
• Support for professional development and continuing education.
• Hybrid work arrangement offering flexibility.
• Contribution to impactful projects in the pharmaceutical industry.