Senior Regulatory Affairs Manager — Global Submissions

Placements24; Houston (TX); On-site; USD 90,000 - 162,000; Full time

Benefits offered by this job

Executive-level benefits including 건강,

Bonuses and long-term incentive plans

Generous paid time off and flexible工作

Professional development including领导培训

Job summary

Placements24 in Randburg, South Africa, is seeking a Senior Regulatory Affairs Manager to oversee regulatory submissions and compliance globally. This strategic role requires deep knowledge of US FDA, EU EMA, and SAHPRA processes, guiding lifecycle management and post-market activities to ensure timely approvals.

You will lead cross-functional teams, mentor staff, and maintain strong agency relationships while aligning local activities with global standards.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, or related discipline.
• Master's or Ph.D. is advantageous.
• Minimum 7 years in regulatory affairs with global submissions.
• In-depth knowledge of US, EU, SA regulatory requirements.
• Experience preparing and submitting regulatory dossiers.
• Excellent strategic thinking, problem-solving, and decision-making.
• Strong leadership and team management.
• Exceptional written and verbal communication; ability to negotiate with agencies.
• Proficiency with regulatory information management systems.
• Ability to manage multiple complex projects in a fast-paced environment.
• Unwavering commitment to regulatory compliance in Gauteng.

Responsibilities

• Develop regulatory strategies to support timely approvals.
• Lead preparation, submission, and review of regulatory dossiers (CTD, ANDA, NDA).
• Ensure ongoing compliance with regulations and company policies.
• Manage post-approval changes and annual reports.
• Act as liaison with regulatory agencies.
• Provide regulatory guidance to R&D, clinical ops, manufacturing, and marketing.
• Conduct regulatory intelligence on evolving requirements.
• Oversee regulatory inspections and respond to inquiries.
• Mentor junior team members.
• Ensure Randburg activities align with global standards.

Skills

Regulatory strategy

Global submissions

Leadership

Regulatory intelligence

Regulatory negotiation

Education

Bachelor's degree in Pharmacy/Chemistry/Biology

Master's or Ph.D. advantageous

Tools

Regulatory information management

Job description

Placements24 in Randburg, South Africa, is seeking a Senior Regulatory Affairs Manager to oversee regulatory submissions and compliance globally. This strategic role requires deep knowledge of US FDA, EU EMA, and SAHPRA processes, guiding lifecycle management and post-market activities to ensure timely approvals.

You will lead cross-functional teams, mentor staff, and maintain strong agency relationships while aligning local activities with global standards.