Regulatory Affairs Manager

Placements24; Pretoria; Hybrid; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Premium health insurance

Retirement contributions

Remote-first with Pretoria office tie

Professional development budget

Job summary

Placements24 is seeking a strategic Regulatory Affairs Manager to lead regulatory operations remotely with strong ties to the Pretoria office. You will develop regulatory strategies, oversee submissions, and liaise with health authorities to ensure compliance and market authorization across territories.

The role requires advanced degrees or equivalent experience, 8+ years in pharma, and at least 3 years in a leadership capacity.

Qualifications

• Advanced degree (e.g., Pharmacy, Law, Sciences) or equivalent experience in regulatory affairs.
• 8+ years of progressive experience in the pharmaceutical industry with 3+ years in management.
• Knowledge of global regulatory requirements (SAHPRA, FDA, EMA) and submission processes.
• Experience in managing regulatory submissions and interactions with health authorities.

Responsibilities

• Develop regulatory strategies for product registration and lifecycle management.
• Prepare, review, and submit regulatory dossiers (e.g., CTD) to health authorities.
• Serve as primary contact with regulatory agencies and respond to inquiries.
• Monitor regulatory changes and assess their impact on products and strategies.
• Provide regulatory guidance to R&D, manufacturing, and commercial teams.

Skills

Leadership

Regulatory strategy

Dossier submission

Stakeholder communication

Education

Pharmacy degree

Law degree

Science degree

Job description

About the Role

Our client is seeking a strategic and experienced Regulatory Affairs Manager to lead their regulatory operations, working remotely with a strong connection to their Pretoria office. This role is crucial for ensuring that all pharmaceutical products meet the stringent regulatory requirements for market authorization and compliance across various territories. You will be responsible for developing and implementing regulatory strategies, preparing submission dossiers, and liaising with health authorities. This is a key leadership position for an individual passionate about navigating the complex regulatory landscape and driving global product approvals.

Key Responsibilities

• Develop and execute comprehensive regulatory strategies for product registration and lifecycle management.
• Prepare, review, and submit regulatory dossiers (e.g., CTD) to health authorities in target markets.
• Serve as the primary point of contact with regulatory agencies, responding to inquiries and facilitating communication.
• Monitor changes in the regulatory environment and assess their impact on the company's products and strategies.
• Ensure compliance with all applicable local and international pharmaceutical regulations and guidelines.
• Provide regulatory guidance and support to R&D, manufacturing, and commercial teams.

Requirements

• Advanced degree (e.g., Pharmacy, Law, Sciences) or equivalent experience in regulatory affairs.
• Minimum of 8 years of progressive experience in the pharmaceutical industry, with at least 3 years in a management or leadership role.
• In-depth knowledge of global regulatory requirements (e.g., SAHPRA, FDA, EMA) and submission processes.
• Proven experience in managing regulatory submissions and interactions with health authorities.
• Exceptional analytical, strategic thinking, and communication skills.
• Ability to lead and mentor a team effectively in a remote-first , globally distributed environment.

Benefits

• Highly competitive salary and executive bonus package.
• Comprehensive benefits including premium health insurance and retirement contributions.
• Significant autonomy and influence over regulatory strategy and operations.
• Professional development budget for training, conferences, and industry events.
• The flexibility and convenience of working remotely, with regular virtual collaboration and team engagement activities.