Senior Regulatory Affairs Manager

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

About the Role

Our client, a globally recognized leader in the pharmaceutical industry, is seeking an experienced and strategic Senior Regulatory Affairs Manager to oversee regulatory submissions and compliance activities in Randburg, Gauteng. This high-impact role requires a comprehensive understanding of global regulatory landscapes, including those of major health authorities like the FDA, EMA, and SAHPRA. The successful candidate will lead the development and execution of regulatory strategies for new product approvals, lifecycle management, and post-market compliance. This position is critical for ensuring our client's innovative pharmaceutical products reach patients efficiently and safely. You will be a key advisor, shaping regulatory approaches and ensuring adherence to all applicable laws and guidelines within the Gauteng region.

Key Responsibilities

• Develop and implement innovative regulatory strategies to support the timely approval of new pharmaceutical products in target markets.


• Lead the preparation, submission, and review of regulatory dossiers (e.g., CTD, ANDA, NDA) to health authorities worldwide.


• Ensure ongoing compliance with all relevant pharmaceutical regulations, guidelines, and company policies.


• Manage post-approval changes, supplements, and annual reports to maintain product registrations.


• Act as the primary liaison with regulatory agencies, building and maintaining positive relationships.


• Provide regulatory guidance and support to cross-functional teams, including R&D, clinical operations, manufacturing, and marketing.


• Conduct regulatory intelligence activities to stay informed of evolving requirements and emerging trends.


• Oversee and participate in regulatory inspections and respond to agency inquiries.


• Mentor and develop junior members of the regulatory affairs team.


• Ensure all regulatory activities conducted from the Randburg office align with global compliance standards.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.


• A Master's degree or Ph.D. is advantageous.


• Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs, with a strong track record of successful global submissions.


• In-depth knowledge of regulatory requirements and guidelines in key markets (US, EU, SA, etc.).


• Proven experience in preparing and submitting various types of regulatory dossiers.


• Excellent strategic thinking, problem-solving, and decision-making skills.


• Strong leadership and team management capabilities.


• Exceptional written and verbal communication skills, with the ability to negotiate effectively with regulatory agencies.


• Proficiency in regulatory information management systems.


• Ability to manage multiple complex projects simultaneously in a fast-paced environment.


• Unwavering commitment to ethical conduct and regulatory compliance in Gauteng.

Benefits

• Highly competitive annual salary: R.


• Executive-level benefits package, including comprehensive health, dental, and vision insurance.


• Performance-based bonuses and long-term incentive plans.


• Generous paid time off and flexible work arrangements.


• Significant opportunities for professional development, including leadership training and international conferences.


• Robust retirement savings plan with employer match.


• Exposure to cutting-edge pharmaceutical development and global markets.


• A prestigious role within a leading pharmaceutical company based in Randburg.