Senior Pharmaceutical Regulatory Affairs Manager

Placements24; Mtubatuba Local Municipality; Hybrid; ZAR 1.100.000 - 1.900.000; Vollzeit

Benefits dieser Stelle

Medical aid

Life insurance

Provident fund

Professional development

Zusammenfassung

Placements24 in Richards Bay, KwaZulu-Natal, seeks a seasoned Senior Pharmaceutical Regulatory Affairs Manager to lead regulatory strategies and submissions across international markets.

You will collaborate with R&D, Clinical, Manufacturing and Quality to ensure compliance, manage CTD submissions, and mentor a growing regulatory team. Hybrid role with on-site collaboration in Richards Bay and remote work options. Competitive benefits package available.

Qualifikationen

• Minimum 6 years of experience in pharmaceutical regulatory affairs.
• Proven track record of regulatory submissions and approvals in major markets.
• Strong knowledge of SAHPRA, FDA, EMA regulatory requirements.

Aufgaben

• Develop and implement regulatory submission strategies for new drug applications and variations.
• Prepare and manage regulatory dossiers for global health authorities.
• Liaise with agencies to facilitate reviews and respond to queries.
• Monitor global regulatory changes and advise on impact.
• Oversee life-cycle regulatory activities including post-approval changes.
• Mentor and manage a team of regulatory professionals.

Kenntnisse

Regulatory strategy

Regulatory submissions

Dossier management

Team leadership

Regulatory intelligence

Ausbildung

Bachelor's or Master's in Pharmacy/Chemistry/Life Sciences

Tools

e-submissions platforms

CTD format knowledge

Jobbeschreibung

About the Role

Our client, a prominent player in the global pharmaceutical market, is looking for a seasoned Senior Pharmaceutical Regulatory Affairs Manager to join their expanding team in Richards Bay, KwaZulu-Natal.

This senior role will be responsible for developing and executing regulatory strategies for the submission and approval of new pharmaceutical products and the maintenance of existing product registrations across various international markets. You will be at the forefront of navigating complex regulatory landscapes, ensuring that Our client's products meet all statutory and regulatory requirements. The position involves close collaboration with internal departments (R&D, Clinical, Manufacturing, Quality) and external regulatory agencies. This hybrid role offers a blend of on-site engagement for collaborative activities and remote flexibility for focused individual work, providing a balanced approach to contribution within the dynamic pharmaceutical sector. Your expertise will be crucial in accelerating drug approvals and ensuring market access for life-saving therapies.

Key Responsibilities

• Develop and implement comprehensive regulatory submission strategies for new drug applications (NDAs) and variations.
• Prepare, review, and manage the submission of regulatory dossiers to health authorities worldwide (e.g., SAHPRA, FDA, EMA).
• Liaise directly with regulatory agencies to facilitate the review process and respond to queries.
• Monitor and interpret changes in the global regulatory environment, advising the company accordingly.
• Ensure that all product labeling and promotional materials comply with regulatory requirements.
• Oversee the regulatory aspects of product lifecycle management, including post-approval changes and renewals.
• Collaborate with R&D, clinical operations, manufacturing, and quality assurance to ensure regulatory compliance.
• Conduct regulatory intelligence activities to identify emerging trends and opportunities.
• Manage and mentor a team of regulatory affairs professionals.
• Participate in due diligence activities for potential acquisitions or partnerships.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum of 6 years of experience in pharmaceutical regulatory affairs.
• Proven track record of successful regulatory submissions and approvals in key markets.
• In-depth knowledge of regulatory requirements in South Africa and major international markets.
• Experience with CTD (Common Technical Document) format and e-submissions.
• Strong understanding of pharmaceutical product development and manufacturing processes.
• Excellent analytical, strategic thinking, and problem-solving skills.
• Superior written and verbal communication skills.
• Ability to manage multiple projects and prioritize effectively in a fast-paced environment.
• Experience in managing regulatory affairs teams is highly desirable.

Benefits

Our client offers a highly competitive salary, a comprehensive benefits package including medical aid, life insurance, and a provident fund. Employees have access to professional development opportunities, including training and attendance at industry conferences. This hybrid role provides flexibility, with on-site collaboration opportunities in our Richards Bay, KwaZulu-Natal office and remote work options. We foster a culture of innovation and professional growth, offering a clear career progression path within a globally recognized pharmaceutical organization. Additional benefits include wellness programs and employee assistance services, supporting a healthy work-life integration for our valued team members.