Pharmaceutical Regulatory Affairs Manager

Placements24; Randburg; On-site; ZAR 1,500,000 - 2,100,000; Full time

Benefits offered by this job

Competitive salary

Bonus potential

Executive benefits

Car allowance

Career development

Job summary

Placements24 is seeking a seasoned Pharmaceutical Regulatory Affairs Manager to lead regulatory strategy and operations from Randburg. The role requires navigating global regulatory landscapes to ensure timely approvals and lifecycle management for our client's therapies.

You will direct regulatory submissions, manage health authority interactions (FDA, EMA, SAHPRA), and guide cross-functional teams through complex challenges with strong leadership and strategic thinking.

Qualifications

• Minimum 7 years in pharmaceutical regulatory affairs with management experience.
• Expertise in global regulatory submissions (FDA, EMA, SAHPRA).
• Strong leadership and cross-functional influence.

Responsibilities

• Develop and implement global regulatory strategies for product registrations and lifecycle management.
• Lead preparation and submission of regulatory dossiers (CTD, MAA, NDA) to authorities.
• Manage agency interactions, respond to queries, negotiate for outcomes.
• Ensure compliance with applicable regulations, guidelines, standards.
• Provide regulatory guidance and training to R&D, manufacturing, quality, and marketing.
• Monitor evolving requirements impacting portfolio and strategy.

Skills

Regulatory leadership

Strategic planning

Project management

Communication skills

Negotiation

Cross-functional collaboration

Team leadership

Education

Master's or Doctoral degree in Pharmacy or related field

Job description

Our client is seeking an accomplished Pharmaceutical Regulatory Affairs Manager to lead their regulatory strategy and operations in Randburg . This senior role requires extensive expertise in navigating global regulatory landscapes to ensure timely approval and lifecycle management of pharmaceutical products. You will be responsible for directing regulatory submission activities, fostering relationships with health authorities, and guiding cross-functional teams through complex regulatory challenges. The ideal candidate will demonstrate strong leadership, strategic thinking, and a deep understanding of pharmaceutical regulations to drive compliance and market access for our client's innovative therapies.

Key Responsibilities

• Develop and implement comprehensive regulatory strategies for new product registrations and lifecycle management globally.
• Lead the preparation, review, and submission of regulatory dossiers (e.g., CTD, MAA, NDA) to health authorities.
• Manage regulatory agency interactions, respond to queries, and negotiate with authorities to achieve successful outcomes.
• Oversee compliance with all applicable regulations, guidelines, and standards for pharmaceutical products.
• Provide expert regulatory guidance and training to internal teams, including R&D, manufacturing, quality, and marketing.
• Stay abreast of evolving regulatory requirements and assess their impact on the company's portfolio and strategic initiatives.

Requirements

• Master's or Doctoral degree in Pharmacy, Law, Life Sciences, or a related field.
• Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs, with significant management experience.
• Demonstrated expertise in global regulatory submission processes and health authority interactions (FDA, EMA, SAHPRA, etc.).
• Strong leadership, strategic planning, and project management capabilities.
• Excellent communication, negotiation, and interpersonal skills.
• Proven ability to interpret and apply complex regulatory requirements and to influence cross-functional teams.
• Experience managing direct reports and leading regulatory affairs teams.

Benefits

• Highly competitive annual salary and bonus potential.
• Executive-level benefits package, including comprehensive medical, dental, and vision coverage.
• Car allowance and fuel benefits.
• Significant opportunities for professional development and executive training.
• Lead a high-performing regulatory affairs team in a key strategic role in Randburg .